Devices and methods for ocular surgery

ABSTRACT

A hand-held aspiration device is provided which has a relatively small suction volume along a suction path to improve responsiveness of the aspiration device when the device is activated. The device may be manually powered and may be provided without electronic controls. The device has a suction path which may be purged into a disposal enclosure to reduce the volume of material under the influence of the suction pressure during the procedure. The suction source may also be part of the hand-held unit to further reduce the suction path and suction volume.

FIELD OF THE INVENTION

This invention generally relates to devices and methods for ocularsurgery with one such procedure being removal of a lens from a humaneye. More specifically the invention relates to capturing, fragmentingand extracting of lenticular or other tissue in ophthalmic surgery.

BACKGROUND

Certain types of conventional ophthalmic surgery require breaking uplenticular tissue and solid intraocular objects, such as the intraocularlens into pieces so that it can be extracted from the eye. For example,extraction of lenses for cataract surgery is one of the most commonoutpatient surgical fields with more than 3 million cases performedannually in the United States alone. During cataract surgery a commonlyused method for lens extraction is phacoemulsification which usesultrasonic energy to break up the lens and then aspirate the lensfragments through the instrument. Other methods of lens fragmentationand extraction may include the use of instruments such as hooks, knives,or laser to break up the lens into fragments and then extract through anincision in the cornea in an ab-interno approach. Intraocular,ab-interno fragmentation of the lenticular tissue is extremely importantin cataract surgery in order to allow removal of cataracts from ocularincisions which are typically not exceeding 2.8-3 mm.

A disadvantage of some lens extraction techniques are unwantedcomplications from aspiration of the lens particularly with the use ofphacoemulsification. Ultrasonic energy and high volume duringphacoemulsification may create turbulent flow which may have adeleterious effect on the tissue within the eye such as the cornealendothelium.

A device or method which is capable of extracting lenticular tissue fromthe anterior chamber without damaging other ocular structures would be asignificant advantage to existing tools and techniques.

Additionally, certain aspiration and inspiration configurations requirelarge pieces of capital equipment as in the case of phacoemulsificationor may require certain resources such as wall vacuum which may not beavailable in all surgical settings particularly in under developedareas.

A device or method which is capable of inspiration or aspiration withless capitally intensive equipment would be a significant benefit tomany surgical settings. The aspiration device may be an independent tubeor cannula or may be associated with another device such as aphacoemulsification unit (“phaco system”). Flow control and pressurecontrol of phaco systems typically requires electronic control by a mainconsole. A handpiece is used which has a suction line extending from thehandpiece to the main console. The handpiece also typically has aninspiration line with inspiration driven by simple gravity feed or byflow controlled by the main console with a fluid bag/cartridge mountedto the console.

Another problem with phaco devices and other devices using a remotevacuum source is that the suction lines are long which means that theywill often contain compressible material during the procedure, such asgas or compressible tissue, which affects the responsiveness of suctionat the tip when suction is turned on and off. The problem ofresponsiveness is exacerbated by manually deformable/compliant hoses andlines which also respond to changes in pressure when starting andstopping suction which further delays initiation and termination ofsuction at the tip. Yet another problem with some systems is that thedisposal enclosure is also exposed to vacuum pressure and, as such, thecontainer and gas or other compressible material therein, also respondsto changes in pressure and further contributing to the delay ininitiation and termination of suction at the tip and contributing to thelow responsiveness of some systems.

Still another problem with conventional methods and devices foraspirating material from the eye is that the suction opening can readilyclog during the procedure. Suction must be stopped and, if necessary,the material removed independently with another instrument inside theeye. The necessity to stop the procedure and unclog the distal openingundesirably increases the procedure time and need for unnecessarymanipulations of the instrument(s) in the eye.

A final problem with some devices is the cost and complexity of thesystems. A lower cost alternative with the same or better performancewould also be desirable alternative such as one not requiring a costlycontrol console and electronic control system.

SUMMARY OF THE INVENTION

What is invented are novel methods and devices for intraocularfragmentation and removal of the lens and other tissues duringintraocular surgery. In various embodiments an ocular surgical device isdescribed which utilizes cutting strings, filaments, snares, baskets,bags, loops and other devices designed to engage and fragment thelenticular tissue and aid in its removal from the eye in a minimallyinvasive, ab-interno approach.

In other embodiments, novel devices and methods for inspiration andaspiration of fluids from the eye are described.

The aspiration device has improved responsiveness compared to some priorart devices using remote suction devices with long manuallydeformable/compliant suction lines. In one aspect of the presentinvention, a hand-held device is provided which may also be powered(manually) by the user and does not require electronic control. Thedevice may further have a short suction path with a small suctionvolume. The device may include a hand-held suction source which, ofcourse, eliminate the need for hoses from the handpiece to the consolethereby greatly reducing the length of line and also the amount ofmaterial subject to the suction pressure which may compress or expand toreduce responsiveness.

In another aspect of the present invention, the device has a purgingmechanism which purges the material from the suction path and into thedisposal enclosure. The purging mechanism may be part of the suctiondevice or may be a separate mechanism. In a specific aspect, the purgingmechanism is a plunger which pushes the material in direction oppositethe suction direction and into the disposal enclosure. A valve, whichmay be a one-way valve, permits the material to enter the disposalenclosure. The valve (or one-way valve) may also prevent the materialfrom entering the disposal enclosure when material is suctioned alongthe suction path during use.

Purging the suction path during the procedure reduces the volume ofmaterial in the suction path compared to systems having long fluid linesto remote suction systems. Purging the suction line may occur in-betweensuction times and may be accomplished using a movable element which alsocreates the suction pressure. In a specific aspect, the movable elementmay be a spring-loaded plunger which is manually set.

In still another aspect, the suction device may include a movableelement within the suction path. For example, the suction device may bethe spring-loaded plunger which is manually actuated. Of course, anyother suction device may be used including a pneumatic system withbladders and/or balloons, a deformable wall and roller system, or anyother suitable system for creating suction pressure such as a venturi.The movable element of the suction device of the present invention mayalso be used to purge the suction path but the two functions may, ofcourse, be separated and performed in different manners withoutdeparting from various and independent aspects of the present invention.

The present invention is also directed to reducing the likelihood ofclogging by providing a restrictor which restricts material in thevicinity of the distal opening. The restrictor reduces the likelihood ofclogging by restricting the material that can enter the distal opening.The restrictor may also be movable (longitudinally and/or rotationally)to clear material from in and around the opening and to gather materialas well.

The present invention also includes a tissue manipulator and method ofmanipulating tissue. The tissue manipulator has a shaft having a lumenwith a distal opening, A first loop has a first leg and a second legwith at least one of the first and second legs extending through thelumen. The first loop is movable from a collapsed position to anexpanded position when the at least one of the first and second legs isadvanced through the lumen and out the distal opening in the lumen. Asecond loop has a first leg and a second leg with at least one of thefirst and second legs extending through the lumen. The second loop beingmovable from a collapsed position to an expanded position when the atleast one of the first and second legs is advanced through the lumen andout the distal opening in the lumen. The shaft may be sized forintroduction of a distal end of the shaft into an eye.

The first loop may have an unbiased shape which bounds an area definedin an orientation that maximizes the area. The area has an effectivediameter which is equal to the diameter of a circle having the samearea. The first loop moves toward the unbiased shape when moving fromthe collapsed position to the expanded position. The effective diameterof the area of the first loop is 4.5 mm to 6.5 mm or can be 5.0 mm to6.0 mm in the expanded position. The effective diameter of the unbiasedshape of the second loop may be within 20% of an effective diameter ofthe expanded position of the first and/or second loops. In this manner,the first and/or second loops provide for a soft deployment and areflexible during use. Use of a superelastic material further enhances theflexibility of the first and second loops. To this end, the first andsecond loops may be formed of superelastic wire having a diameter ofabout 0.003 inch although any size may be used with any suitablecross-sectional shape.

The tissue manipulator may also include an intermediate elementpositioned between the first loop and the second loop. The intermediateelement may be a third loop positioned between the first loop and thesecond loop. The intermediate element may include an interconnectingelement extending between the first loop and the second loop. Theinterconnecting element may be integrally formed with the first loop andthe second loop. Alternatively, the interconnecting element may be aflexible filament extending between the first loop and the second loop.The third loop may have the features of the first and second loops.

The first and second loops provide a controlled amount of exposedsurface therebetween to control, and optionally cut, a controlled amountof the material. The exposed surface between the first loop and thesecond loop has an area of 15 mm(3) to 60 mm(3). Stated another way, theexposed surface between the first loop and the second loop is 3-10 timesthe effective diameter in the expanded position (or the unbiasedposition since they may be the same).

The exposed surface between the first loop and the second loop may have2-8, 2-6, 2-4 or even just 2 independent cells when viewed in a radiallyinward direction relative to the orientation axis of the first andsecond loops. The exposed surface has an area which is at least 4 timeslarger than an surface area of the intermediate element when expandedbetween the first and second loops and viewed radially inward withrespect to the loops. In this manner, the intermediate element does nottake up an excessive amount of room as compared to some net-typedevices.

The device may include a first support element extending from a distalend of the shaft when the first loop is expanded. The first supportelement may be an elongate element that extends to a free end. The firstsupport element is positioned with the free end positioned within anarea of the first loop when viewing the first loop along an orientationthat maximizes the area of the first loop. A second support elementwhich cooperates with the second loop in the same manner may also beprovided. The first loop and/or second loop may have at least oneinterconnecting element extending from a first connection to the firstloop to a second connection to the first loop or may be substantiallyfree of any such interconnecting elements depending upon the desireduse.

In yet another aspect of the present invention, the tissue manipulatorhas a concave element coupled to a first loop to form a basket. Theconcave element may have one end integrally formed with the first loopwith the other end movable within the lumen independent of the first andsecond legs. Alternatively, both ends may be integrally formed with theloop. A second loop having another concave element may be provided toform another basket with the two baskets being movable relative to oneanother between a nested position and a position in which the twobaskets oppose one another.

In use, the device is introduced into the eye with a distal end anddistal opening of the shaft inside the eye. The first loop is expandedand the second loop is also expanded (simultaneously or independently).Material is positioned within the first and/or second loop and then thefirst and/or second loop is collapsed around the material to contain,manipulate or cut the material. Furthermore, a suction source may becoupled to the lumen to suction the material, fluid, and the cutmaterial into the lumen or another lumen. The method may include allfeatures of the device which are expressly incorporated here for allpurposes.

In another aspect of the present invention, another device is providedwhich has a shaft having an elongate element that is bowed outwardly bybiasing the elongate element with a load when deployed. The loop ismovable from a collapsed position to an expanded position when a firstshaft part (coupled to the first end of the elongate element) and asecond shaft part (coupled to the second end of the elongate element)are moved relative to one another from a first position to a secondposition. Material is positioned in the loop and then cut by collapsingthe loop. The loop may be expanded so that the loop advances between thecapsular bag and a whole lens contained within the capsular bag.

The elongate element may have a first and a second flexible portion withan intermediate portion therebetween which is at least 1.5 more stiff inbending than the flexible portions. In another aspect, the first end maychange in orientation relative to the proximal end of the shaft whendeployed. The change in orientation may be provided by simply pinning orotherwise rotatably coupling the first end to the shaft so that theangle (orientation) changes by at least 120 degrees or 180 degrees+/−45degrees when the first and second shaft parts move from the firstposition to the second position. The distal end of the shaft may alsoinclude a flexible portion which changes in orientation relative to theproximal portion of the shaft when the loop is expanded. The distal endmay change in orientation by at least 30 degrees. The first end rotatesso that the loop advances distally beyond a distal end of the shaft asthe loop moves from the collapsed position to the expanded position. Thesecond end may also be rotatably coupled to the shaft or may include theflexible portion. Use of and discussion of all aspects of the firstflexible portion or the first end are equally applicable to the secondend and are specifically incorporated herein. Furthermore, a mixture offirst end and second end are also expressly incorporated such as aflexible first end and a rotatable second end.

These and other aspects and features will become evident from thefollowing description of the preferred embodiments, drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a device for suctioning material.

FIG. 2 shows another device for suctioning material.

FIG. 3A shows still another device for suctioning material.

FIG. 3B shows an alternative suction source using a bellows.

FIG. 4 shows yet another suction device using a venture.

FIG. 5 shows still another suction device having a bladder as thesuction source.

FIG. 6A shows a flow restrictor covering an opening in a shaft and in astored position in the dotted-line position.

FIG. 6B shows the flow restrictor movable longitudinally relative to theshaft with the dotted line position showing a working position.

FIG. 6C shows show an alternative shaft having a y-arm.

FIG. 7 shows an end view of the flow restrictor.

FIG. 8A shows a tissue manipulator in a collapsed position within alumen of a shaft.

FIG. 8B shows the tissue manipulator expanded with filaments extendingbetween loops.

FIG. 8C shows another view of the loops with the filaments removed.

FIG. 9 shows another tissue manipulator with integrally formedintermediate elements.

FIG. 10 shows another tissue manipulator with integrally formedintermediate elements.

FIG. 11 shows still another tissue manipulator with a net-like materialwithin the loops.

FIG. 12 shows still another tissue manipulator having a loop with anintegrally formed concave element.

FIG. 13 shows still another tissue manipulator with a rotating cutter.

FIG. 14 shows another tissue manipulator with a net-like material.

FIG. 15 shows still another tissue manipulator.

FIG. 16 shows a tissue manipulator having two opposing baskets.

FIG. 17 shows the opposing baskets in a nested position.

FIG. 18A shows a device for cutting material within the eye.

FIG. 18B shows a side view of the device of FIG. 19A.

FIG. 18C shows the device of FIG. 19A with an elongate element deformedto expand a loop formed by the device.

FIG. 18D shows the device of FIG. 19C further expanded.

FIG. 19 shows the device of FIG. 19A-D full expanded and positionedwithin a capsular bag and advanced between the capsular bag and the lenswhen the loop is expanded.

FIG. 20A shows another cutting device in a collapsed position.

FIG. 20B shows the device of FIG. 21A partially expanded with the distalend changing orientation with respect to the proximal end of the shaft.

FIG. 20C shows a loop formed by the device advancing distally.

FIG. 21A shows the loop expanded further.

FIG. 21B shows the loop expanded with the proximal end of the elongateelement also changing orientation with respect to the shaft.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

During cataract surgery it is desirable to have a supply of balancedsaline solution (BSS) delivered to the eye as well as a supply ofsuction to remove fluids and other materials. Certain ophthalmicsurgical tips have the ability to inspirate and aspirate fluid throughdual lumen designs. These devices must be connected to a supply ofsuction and pressurized BSS fluid.

In some embodiments, the invented device includes the ability to providesuction or BSS pressurized fluid through simple mechanisms, some ofwhich may be manually powered or regulated. In FIG. 1 a separate plungerdevice is shown which may be depressed in order to create a vacuum whichprovides suction when connected to the hand piece. The hand piece mayalso be connected to a pressurized BSS source such as a hanging bag orany number of other pressurized sources such as spring loaded syringesand the like. Alternatively vacuum may be supplied by any number ofother mechanisms such as a bellows mechanism, diaphragm pump, venturipump, entrapment pump, positive displacement pump, regenerative pump,momentum transfer pump, sealed containers of vacuum that are released,micro pumps, or the like. When connected to a hand piece, suction issupplied to the tip to provide aspiration. In one embodiment, acompressible bulb such as a turkey baster may be used to providesuction. The user may depress the bulb with a finger and control theamount of suction by the release of the finger from the bulb. Otherlever mechanisms may additionally create vacuum in a hand heldinstrument. In some embodiments, a nurse or assistant may create vacuumwith a device that is connected to the hand held instrument. Forexample, a foot pedal may be used to create suction that is connect tothe surgeons device. The hand piece may contain any number of wastecontainers that contain the withdrawn fluid and store it in the handpiece or off the hand piece. The various vacuum mechanisms may bepowered in any number of ways such as a manual operation by the user orassistant. In this embodiment, the user may ‘charge’ the device withenergy such as by depressing a spring loaded plunger before beginningthe procedure and then controlling the amount of vacuum with a valve orother input mechanism. In some embodiments, the BSS pressurized supplymay be coupled to the hand piece and may be ‘charged’ at the same timeas the vacuum or separately. For example, the surgeon may depress oneplunger that creates a spring force on the vacuum and the BSS fluid suchthat the surgeon may control the release of both with a single button ormultiple buttons during the procedure. In other embodiments, the BSS maybe in a hanging bag or other pressurized system and piped into thehandpiece.

In some embodiments, the hand piece may include a flow control valve foradditionally allowing the surgeon to select the rate or pressure of thefluids aspirated or inspirated. The surgeon may adjust the amount offlow desired by rotating a knob that compresses a tube a certain amountor opens a ball valve a certain amount or any number of other flowcontrol mechanisms. The device may also include a button that can bedepressed to regulate when the device is inspirating or aspirating. Theamount the surgeon depresses the button may in itself control thevariable flow. There may be a single button for controlling inspirationand aspiration or individual buttons for each. It should be understoodthat button simply means a control interface for the user and that anynumber of interfaces may be contemplated. Additionally the controlinterface may be on the hand held device or may be in another location.For example a foot pedal may be used to control the flow or a separatedevice held with a different hand may be used.

In some embodiments, the device may include a dual lumen design forinspiration and aspiration. In other embodiments, there may be more than2 lumens or the lumens may be oriented concentrically.

In various other embodiments, device and methods for the removal orfragmentation of the lenticular tissue is described. Bags or mesheswhich are attached to snares or loops may be incorporated to grablenticular tissue that is either whole or partially fragmented. The bagsand meshes may be used to pull the tissue from the eye through aparacentesis. In some embodiments, a separate tool may be inserted intothe bag or mesh after a fragment of the lens is captured and theseparate tool may be used to break the tissue into smaller fragments.For example, a spinning cutter instrument may be inserted either with adifferent device or through a lumen of the bag device to cut the tissueinto smaller pieces while it is within the bag or container so that maybe withdrawn through the paracentesis.

In other embodiments, various baskets are used to capture the lensmaterial and either pull it from the eye or further fragment thematerial into smaller pieces that may be aspirated. In each embodiment,the bags and meshes and baskets may be made of any number of materials.For example, nitinol material may be used and shaped into the properorientation. Certain material such as nitinol may be elastically changedbetween multiple shapes and used to enter the eye through a smallprofile and expand within the eye to capture the lens material. Anynumber of shapes are contemplated such as coin purses, expandingballoons, curved bags, and the like. The devices may be comprised anyplurality of materials such as stainless steel, nitinol, biocompatibleplastics, and the like. Additionally, nitinol may be used in either itssuper elastic state or shape memory state or both in multiplecomponents.

In some embodiments, cutter and augers and the like may be used tomechanically fragment the lens into multiple pieces. These devices mayadditionally include integrated suction for the aspiration of the lensmaterial.

The aspects of the invention mentioned above are applicable to allsuitable embodiments described herein. Thus, use of nitinol as describedabove is applicable to all suitable aspects concerning any cuttingfilament, element or device described herein. Similarly, any aspect ofthe aspiration device described above are equally applicable to allaspiration embodiments described herein. Finally, the features, aspectsand methods of using each of the devices and methods is equallyapplicable to the other devices and methods described herein (includingcutting) and all such features are expressly incorporated herein.

Referring to FIG. 1, a device 2 for removing material during procedureson the eye is shown. The device 2 has a suction path 4 which extendsthrough a lumen 6 to an opening 8 in the lumen 6 at or near a distal end12 of the lumen 6. The opening 8 is positioned in the eye for removal ofmaterial from the eye. A suction source 14 is coupled to the suctionpath 4 to draw material into the opening 8. The suction source 14 is amanually loaded spring 16 coupled to a plunger 18 but may be any othersuitable source. The suction source 14 is also hand held providing for ashort suction path 4 and the benefits of such a short path and smallsuction volume within the suction path 4.

The suction path 4 has a proximal suction volume 21 which may besubstantially under the influence of suction pressure by the suctionsource 14 at all times so that the system is prepared or “primed,” in asense, to suction material. An actuator 20 is positioned near theopening 8 with the proximal volume of the suction path 4 less than 25 mland already under suction pressure proximal to the actuator. Theproximal volume is defined by the volume of the suction path 4 betweenthe actuator and the suction source 14 (in this case the plunger 18). Adistal volume 23 of the suction path 4 is also small since the actuator20 is positioned relatively near the opening 8 and may be less than 2ml. The actuator may be movable to a number of different positions andmay be continuously variable to allow for the desired amount of suctionby the user as described herein and specifically incorporated here. Theterm actuator 20 is used herein to refer to the element that acts on thesuction path 4. A button 25 acts as an interface, however, the button orinterface may be remote to the actuator 20. In this case, the button 25acts directly on the actuator and may also have elastic propertiesitself.

The suction source 14 may have a movable element 29, such as the plunger18, which is displaced in a direction shown by arrow A to draw thematerial into the opening and through the suction path 4. The movableelement is displaced in an opposite direction to the direction A to movematerial into the suction path 4 into the disposal enclosure asexplained in greater detail below in association with purging of thesuction path 4.

The suction source 14 is hand-held in that the movable element is partof a hand held unit. The device also may have no electronic control andno electric powered parts and may even be powered by the user in thatthe spring 16 is manually loaded (extended). The movable element 29 iscoupled to the spring 16 to manually load the movable element 29 with aspring load. The movable element 29 may be a piston, a plug, stopper,ball or a movable part of a wall such as a bladder or balloon. Onceloaded, the movable element 29 continuously exerts suction pressureuntil the spring 16 is completely relaxed or otherwise restrained.

The actuator 20 also serves as a valve for the suction path 4 and mayact on a deformable part 31 of the suction path 4. The opening 8 isexposed to suction pressure refers to the fact that suction pressure maybe applied by exposing the opening to the suction pressure whenactivating the actuator. Alternatively, the opening 8 may be exposed tothe suction pressure when activating the suction device itself. Forexample, even the spring-loaded mechanism of the device 2 may be coupledto a controller (not shown) so that suction pressure is applied andreleased and, when applied, exposes the opening 8 to suction pressure todraw material into the opening. Of course, responsiveness may beaffected but other aspects of the present invention may, nevertheless,be practiced with on-demand suction. The actuator 20 may be continuouslyvariable by simply depressing more or less to deform more or less of thedeformable portion 31 between at least two different open positions.FIG. 1 shows a continuously variable actuator between the fully open andfully closed positions by simply varying the amount the deformable part31 is deformed.

A disposal enclosure 40 is coupled to the suction path 4 to receivematerial from the suction path 4. A valve 42, such as a one-way valve,is positioned between the disposal enclosure 40 and the suction path 4.The valve 42 permits material to move to the disposal enclosure 40 andisolates the disposal enclosure 40 during suction operation. The valve42 may be an actuated valve or a passive one-way valve which opens andcloses automatically as necessary. The valve 42 isolates the disposalenclosure 40 so that the compressibility of the material does not affectthe responsiveness of the system as described herein. The suction path 4may increase in diameter at parts outside the eye similar to or the sameas a syringe. Furthermore, the suction path 4 may take any shape withoutdeparting from the invention.

The disposal enclosure 40 is configured to be supported independently,for example, by the table a traditional hanger, or any other suitablestructure. Furthermore, aspects of the present invention may bepracticed with the disposal enclosure 40 hand-held or remotely locatedwithout departing from aspects of the invention. The disposal enclosure40 has a disposal lumen 45 extending from the suction path 4 to thedisposal enclosure. As mentioned above, the valve 42 (or one-way valve)isolates the disposal enclosure 40 from the suction pressure therebypreventing any pressure response by the disposal enclosure 40 duringuse. Of course, aspects of the present invention may be practicedwithout the valve 42.

The device 2 is hand-held to a large extent in that the suction path 4is hand-held and the suction source 14 is hand-held as well. Within themeaning of the present invention, the suction source 14 does not includetubing or the like from the suction machine but defines the mechanicalsource that is creating the suction pressure. Although the presentinvention describes specific suction mechanisms and devices any othermay be used. For example, a roller with tubing, a pneumatic system, abladder or venturi may be used to create suction pressure withoutdeparting from aspects of the invention. The suction path 4 may also bemore than half non-manually deformable or even at least 90% non-manuallydeformable. Most systems with remote suction devices include manuallydeformable tubes and hoses which may respond to pressure changes whichfurther reduces responsiveness. The suction path 4 may be small tofurther improve responsiveness. To this end, the suction path 4 may havea length (longitudinal) L of less than 20 cm or a volume of less than 25ml and even less than 15 ml.

As mentioned above, the present invention is particularly useful forremoving material from the eye. As such, the lumen 6 may beappropriately sized. The suction path 4 includes a shaft 51 having thelumen 6. The lumen is sized for introduction into the eye and has alongitudinal axis with a cross-sectional area of the outer perimeter (ordiameter) of the shaft 51 being no more than 0.8 mm(2) while the lumenhas a cross-sectional area of at least 0.28 mm(2).

The plunger 18 is also operated to manually purge the suction path 4.Purging the suction path 4 reduces the material in the suction path 4when suction is reinitiated. In this manner, the devices and methods ofthe present invention provide improvements in responsiveness compared tosystems having long lines containing relatively large amounts ofmaterial between the handpiece and remote suction source 14.

A purging mechanism 55 may be the movable element 29 (plunger 18) or maybe a separate element which moves the material from the suction path 4to the disposal enclosure. In one aspect, the purging mechanism movesthe material through the suction path 4 in an opposite direction tosuction of material along the suction path 4 as shown by arrow A. Thevalve 42 permits flow from the suction path 4 to the disposal enclosure40 when the movable element 29 is advanced. The purging mechanism 55 mayalso include an element separate from the movable element 29 which formspart of the suction device and may be completely independent of thesuction source 14. As defined herein, the suction path 4 includesvolumes occupied by movable elements 29. For example, the plunger 18moves between fully retracted and fully advanced positions with thesuction path 4 essentially changing in length and in volume. As usedherein, the defined length and volume of the suction paths shall bedefined with the minimum volume contained therein by the suction source14. Thus, the length and volume is defined by the most advanced positionof the plunger/movable element that minimizes the length and volume.

As described herein, “compressible” material such as a gas may alsorefer to the “expansibility” of the material in that suction pressureapplied to entrained gas and material may permit the gas and material toexpand slightly under the lower suction pressure (rather than compress).The compressibility (or expandability) of gasses and the effect onpressure responsiveness is typically deemed a problem of“compressibility” of gasses and is also so described herein and it isunderstood that this term also applies to the expandable nature ofgasses and materials. With respect to the hoses and lines, the abilityto resist compression by the suction pressure is a material propertyrelevant to the responsiveness of such systems with manually deformablematerials typically also responding mechanically to pressure variations.

Referring to FIG. 2, another suction device 102 is shown wherein thesame or similar reference numbers refer to the same or similarstructure. The suction source 114 is also a plunger 103 which ismanually loaded with a spring 105. The spring 105 is loaded with apivoting lever 107 attached to a housing 109. The disposal enclosure 111is also mounted to and within the housing 109 and is hand-held with thedevice 102. Pressing the lever 107 advances the plunger 103 to purge thematerial in suction path 4 to the disposal enclosure 111. A first valve113 and a second valve 115 (which may be one-way valves) permit suctionthrough the lumen and purging of material into the disposal enclosure111.

The lever 107 may be selectively locked and unlocked once advanced orthe user may continue to apply pressure to the lever 107 to essentiallystop suction. When suction is desired again, the lever 107 may bereleased with variable pressure to vary the amount of suction produced.Alternatively, the first valve 113 may include an interface 115, such asa button, which is actuated to open and close the suction path 104. Theinterface 114 may act as an actuator described herein and separates aproximal volume 117 from a distal volume 119 of the suction path 104.The first valve 113 may be formed over a deformable portion 121 of thesuction path 104 along the valve 113 for use as described herein and allsuch uses of the deformable portion and actuator are expresslyincorporated here. The second valve 115 (which may be a one-way valve)regulates flow to the disposal enclosure 111. A source of irrigationfluid 121 is also coupled to the shaft for irrigating the eye using asource of irrigation fluid 121. The source of irrigation fluid 121 maybe a gravity fed bag or part of a fluid delivery system such as a phacosystem. An irrigation lumen 123 has an opening 125 positioned in the eyefor delivery the irrigation fluid.

Referring to FIG. 3A, another suction device 302 is shown wherein thesame or similar reference numbers refer to the same or similarstructure. The suction source 314 is also a plunger 318 or movableelement 329 which is manually loaded with a spring 316, however, thesuction source 314 is remote from the hand-held housing 331. The springis loaded manually. An irrigation source 121, such as a bag of balancedsaline solution, is coupled to an irrigation lumen 323. A valve 325controls flow of the irrigation fluid. The actuator 320 is used in thesame manner as the actuator 20 above and suction path 304 includes thedeformable portion 331 and all aspects and methods of these elements areincorporated expressly here. Purging of the suction path 104 is alsoaccomplished in the same manner with the material moving into thedisposal enclosure when the movable element 329, such as the plunger318, is advanced. A valve 342 may be are provided in the same manner asdescribed above for controlling the flow into the disposal enclosure 40and discussion of these aspects are also incorporated here.

Referring to FIG. 3B, the suction source 314 may also be a bellows 350(rather than the plunger) which may be actuated by foot with a footpedal. The bellows 350 are biased to an open position so that thebellows 350 provides suction after the foot pedal is depressed. Similarto other embodiments, when the bellows 350 is compressed by the user'sfoot the material within the bellows 350, which also constitutes part ofsuction path 304 as described herein, is moved to the disposal enclosure340.

Referring to FIG. 4, yet another suction device 402 is shown wherein thesame or similar reference numbers refer to the same or similarstructure. The device 402 has a venturi 406 coupled to a source ofpressurized gas 408. The venturi 406 directs the pressurized gas towardthe disposal enclosure 440 which also directs the material withinsuction path 404 also toward the disposal enclosure 440. The venturi 406also acts as the suction source 414 producing suction pressure along thesuction path 404. The suction path 404 includes a 415 chamber incommunication with the venturi 406 so suction pressure is created in thechamber 415 by the venture 406. The venturi 406 is opened and closedwith a pivoting lever 421.

Referring to FIG. 5, another suction device 502 is shown wherein thesame or similar reference numbers refer to the same or similarstructure. The suction source 514 has a movable element 529 which abladder 531 which is deformed manually by the user. Once compressed,compression is maintained on the bladder 531 to stop suction and reducedto produces suction. Stated another way, the bladder 531 is moved froman unbiased stated to a compressed state with the user releasingcompression to begin suctioning material into the opening 508. Movementof the bladder 531 from the unbiased state to the compressed state mayalso move material from the suction path 504 (which includes theinternal volume of the bladder) to the disposal enclosure. A first valve513 may also include an interface, such as a button 533, so that thefirst valve 533 acts as the actuator described herein and separates aproximal volume 535 from a distal volume 537 of the suction path 504.The first valve 513 may be formed over a deformable portion 541 of thesuction path 504 along the valve 513 as described herein. A second valve543 (which may be a one-way valve) regulates flow to the disposalenclosure 545. An irrigation source 547 may also be provided with aspring loaded delivery 549 coupled to an actuator (not shown).

All aspects and methods of the suction devices described herein areapplicable to the other suction devices and all such methods and aspectsare expressly incorporated for each from the others. For example, thesuction path length and volume as well as dimensions of the lumen andshaft are applicable to each of the other suitable embodiments describedherein.

Referring now to FIGS. 6A-6C, a suction tip 600 is shown for suctioningmaterial from the eye. The suction tip 600 has a shaft 602 with a lumen604 extending through the shaft 602. A distal opening 608 in the shaft602 has an area which is defined by an opening axis OA which maximizes asize of the opening 608. The opening area may be circular, oval or anyother suitable shape. The opening area defines an effective diameterdefined as the diameter equivalent for a circle having the same area asthe opening area.

The suction tip also 600 has a restrictor 610 which extends over thedistal opening 608 when viewed along the opening axis OA. The restrictor610 has a support arm 612 extending from the shaft 602. The restrictor610 may have a stop 614 attached to the support arm 612 with the stop614 spaced apart from the distal opening and positioned over the distalopening when viewed along the opening axis as shown in FIG. 7. Therestrictor 610 is spaced apart from the distal opening 0.80 to 1.10times, or 0.85 to 1.00 times, the effective diameter measured along theopening axis and aligned with the distal opening when viewed along theopening axis. The restrictor 610 also may optionally extend a shortdistance from the distal end of the shaft so that it does not impedeuse. To this end, the restrictor 610 may have a distal end 615 thatextends no more than 1.5 times the effective diameter from the distalopening measured along the opening axis. The restrictor has an area whenviewed along the opening axis which may be 0.1 to 1.2 times the area ofthe distal opening when viewed along the opening axis. Thus, therestrictor may be somewhat small when less concerned with moving,gathering or clearing material from the opening.

The support arm 612 may have an angular extent B when viewed along theopening axis of no more than 90 degrees as shown in FIG. 7. The distalopening 604 may be free of obstruction apart from the support armbetween the distal opening and a stop on the restrictor when viewedalong the opening axis OA. The restrictor 610 forms a feed opening 622leading to the distal opening 604 when the restrictor 610 is in theworking position shown by the dotted-line position of FIG. 6B. The feedopening 622 defines a surface 626 extending between and defined by therestrictor 610 and a distal end of the shaft 623 around the opening 604.The surface 626 may be an elongate surface that, essentially, extendsfrom one side of the support arm 612 to the other. In this manner, anaverage length of the surface is 2.5-3.5 times the effective diameter.The surface may have a width of 0.8 to 1.1 times the effective diameter.

The support arm 612 may be longitudinally and/or rotatably movablerelative to the shaft to adjust a longitudinal or rotational position ofthe support arm as shown in the dotted-line and solid line positions.The support arm 612 is movable from a working position (as definedabove) to a displaced position with the working position being aposition used when suctioning material into the distal opening. Theshaft has a longitudinal axis LA and the restrictor is formed with thesupport arm 612 rotating and/or longitudinally displaceable. Therestrictor 610 may be formed so that the displaced position movesmaterial toward the distal opening 608. The restrictor 610 may also beextended outwardly to help gather or otherwise organize material to besuctioned. The restrictor 610 may be movable to a position which is atleast two effective diameters from the distal opening 608 measured alongthe opening axis.

The restrictor 610 may be mounted over the shaft, for example, in aconcentric manner although an interlocking or independent lumens may beused without departing from the scope of the invention so long as therestrictor 610 is over the shaft and outside the lumen in someembodiments. The restrictor 610 is movable to a stored position in whichthe entire restrictor is positioned proximal to the distal opening andoptionally completely outside the lumen as shown in the dotted-lineposition of FIG. 6A. Thus, the user may elect to use the suction devicewithout restriction, for example, when the likelihood of clogging theopening is low. The restrictor 610 may be deformed when in the storedposition and, to this end, the restrictor 610 has a living hinge 640with the support arm 612 forming part, or all, of the living hinge 640which is deformed in the stored position.

The stop 614 may be part of the support arm 612 in that the distal endof the support arm 612 simply forms the stop 614. Furthermore, therestrictor 610 may also simply be part of an extension of the shaftwithout departing from various aspects of the present invention.Finally, the restrictor 610 and methods associated with the restrictor610 may be used with any of the other devices described herein includingthose associated with cutting and/or removing the lens. Furthermore, thedevices may be used through the lumen of any of the devices describedherein by simply providing a y-arm 642 and a suitable connector 641which forms a seal around the cutting device. Thus, the lumen may be asubstitute for any lumen described herein and the method of cutting thelens in combination and aspirating material and the device combinationincluding any lens cutting device coupled with any aspirating devicebeing specifically incorporated herein. For example, referring to FIGS.6B and 6C, a seal is provided at the Y-arm 642 in the lumen and suctionpath through which any of the cutting devices described herein (oranother cutting device) may be introduced. FIG. 6B shows the sealcentrally located rather than on a Y-arm so the cutting device extendsdirectly through the lumen with suction in the annular space between thecutting device and the shaft. Furthermore, an irrigation lumen, whichmay be concentric or separate, may be provided and the process ofirrigating may be practiced with any method or combination methoddescribed herein and such methods are specifically incorporated here asshown in one or more embodiments and expressly incorporated into thosewhich do not.

In use, the distal end of the shaft is positioned in the eye for anyprocedure on the eye including cataract surgery. During cataract surgerypieces of the cataract are removed using suction. The present inventionmay be used for this purpose as now described. Material is suctionedinto the distal opening by applying suction which draws material intothe distal opening. The restrictor 610 may help to reduce clogging ofthe distal opening compared to conventional suction devices which permitunrestricted flow toward the distal opening. As mentioned above, aproblem with the conventional method is that material which is largerthan the suction opening is free to approach and, thus, clog theopening. Suction must be stopped and, if necessary, the material removedindependently by another instrument. The present invention is directedto reducing the likelihood of clogging by providing the restrictor. Thepresent invention may be used with any device including a stand-aloneaspiration device, a re-usable phacoemulsion tip, or a disposable aspectof any aspiration device.

In another aspect of the present invention, a tissue manipulator 660 andmethod of manipulating tissue are described. The tissue manipulator 660has a shaft 662 having a lumen 664 with a distal opening 668. A firstloop 670 has a first leg 672 and a second leg 674 with at least one ofthe first and second legs 672, 674 extending through the lumen 664. Thefirst loop 670 is movable from a collapsed position of FIG. 8A to anexpanded position of FIG. 8B when the first and second legs are advancedthrough the lumen 664 and out the distal opening 668. A second loop 676has a first leg 678 and a second leg 680 with the first and second legs678, 680 extending through the lumen 664. The second loop 676 is alsomovable from a collapsed position to an expanded position when the firstand second legs are advanced through the lumen and out the distalopening 668. The shaft 662 may be sized for introduction of a distal endof the shaft into an eye.

The first loop 670 may have an unbiased shape which bounds an areadefined in an orientation OR that maximizes the area. The area has aneffective diameter which is equal to the diameter of a circle having thesame area. The first loop 670 moves toward the unbiased shape whenmoving from the collapsed position to the expanded position. Theeffective diameter of the area of the first loop is 4.5 mm to 6.5 mm orcan be 5.0 mm to 6.0 mm. The effective diameter of the unbiased shape ofthe first and/or second loops may be within 20% of an effective diameterof the expanded position of the first and/or second loops, respectively.In this manner, the first and/or second loops provide for a softdeployment and are flexible during use. Use of a superelastic materialfurther enhances the flexibility of the first and second loops. To thisend, the first and second loops 670, 676 may be formed of superelasticwire having a diameter of about 0.003 inch although any size may be usedwith any suitable cross-sectional shape.

The first and second loops are each defined by the orientation OA whichmaximizes an area of the first loop and second loop when in the expandedposition when viewed along each orientation. The orientation of thefirst and/or second loop may be within 45 degrees of perpendicular tothe longitudinal axis LA at a distal end of the shaft. The first loop670 is spaced apart from the second loop 676 to define a volume Vtherebetween when the first and second loops are in the expandedposition with the volume therebetween being 48-84 mm(3).

The tissue manipulator 660 may also include an intermediate element 680positioned between the first loop 670 and the second loop 676. Theintermediate element 680 may be a third loop 682 positioned between thefirst loop 670 and the second loop 676. The intermediate element 680 mayinclude an interconnecting element 682 extending between the first loop670 and the second loop 676. The interconnecting element 682 may beintegrally formed elements 681 with the first loop and the second loopas shown in FIGS. 9 and 10. Alternatively, the interconnecting elementmay be a flexible filament 684 extending between the first loop and thesecond loop as shown in FIG. 8B. The third loop 682 may have thefeatures of the first and second loops. The orientation OA whichmaximizes an area of the third loop may be within 30 degrees ofperpendicular to the longitudinal axis LA.

The first and second loops provide a controlled amount of exposedsurface therebetween to control, and optionally cut, a controlled amountof the material. The exposed surface ES between the first loop 670 andthe second loop 676 has an area of 15 mm(2) to 60 mm(2). Stated anotherway, the exposed surface between the first loop and the second loop is3-10 times the effective diameter in the expanded position (or theunbiased position since they may be the same).

The exposed surface between the first loop and the second loop may have2-8, 2-6, 2-4 or even just 2 independent cells when viewed in a radiallyinward direction relative to the orientation axis of the first andsecond loops 670, 676. The exposed surface ES has an area which is atleast 4 times larger than an area of the intermediate element 680positioned between the first loop and the second loop 670, 676 when theexposed surface ES is viewed radially inward with respect to the firstand second loops 670, 676. In this manner, the intermediate element 680does not take up an excessive amount of room as compared to somenet-type devices.

The first loop 670 may also be formed so that at least 80% of the loopis 1.5-3.5 mm from the second loop 676. The first and second loops 670,676 (and optional intermediate element) may also be configured to cutmaterial contained within therein when collapsed. A source of suctionmay be coupled to the lumen with suction being used together with orseparately from the tissue manipulator. Irrigation may also be suppliedwith the other shafts incorporated herein and such incorporation isexpressly provided here.

The device 660 may include a first support element 690 extending from adistal end of the shaft when the first loop 670 is in the expandedposition. The first support element 690 may be an elongate element thatextends to a free end 691. The first support element 690 is positionedwith the free end 691 positioned within an area of the first loop 670when viewing the first loop along the orientation OA that maximizes thearea of the first loop 670. The first loop 670 has an effective diameterwhen in the expanded position while the first support element 690extends into the area of the first loop so that the free end ispositioned 0.05 to 0.30 times the effective diameter of the first loopwithin the first loop 670 when viewed along the orientation OA. A secondsupport element 692 cooperating with the second loop 676 in the samemanner may also be provided.

Referring to FIG. 11, the first loop and/or second loop may have atleast one interconnecting element 695 extending from a first connection696 to the loop to a second connection 697 on the same loop or theloop(s) may be substantially free of any such interconnecting elementsdepending upon the desired use. For example, a net-like material asshown in FIG. 11 may be provided or the loops may be free ofinterconnecting elements so that the open area is free. All discussionand limitation of the first loop are applicable to the first loop, thesecond loop and the third loop as well as discussion of the firstsupport applicable to the second support. The first support may extendindependently or simultaneously with the first loop. The first supporthelps to secure material within the first loop by extending into theopening area formed by the loop.

The first and second legs of the first and second loop(s) may be movablewithin the lumen. Alternatively, the first leg and the second leg of thefirst loop are coupled to an actuator extending through the lumen sothat movement of the actuator moves the first leg and the second legbetween the collapsed position and the expanded position. The first legand the second leg of the second loop are coupled to an actuatorextending through the lumen so that movement of the actuator moves thefirst leg and the second leg between the collapsed position and theexpanded position. The first loop and/or the second loop may bepositioned entirely distal to the distal opening in the expandedposition. The first loop and the second loop may include a superelasticmaterial within a superelastic range when in the collapsed position.

Referring to FIG. 12, a tissue manipulator 700 has a concave element 702coupled to a first loop 704 to form a basket 706 to receive material.The concave element 702 may have one end 708 integrally formed with thefirst loop 704 with the other end 710 movable within a lumen 712 of ashaft 713 independent of a first leg 714 and a second leg 716 of thefirst loop 704. Cross-elements 715 are also integrally formed with thefirst loop 704 and may also be integrally formed with the concaveelement 702. Alternatively, both ends 708, 710 may be integrally formedwith the loop 704.

Another tissue manipulator 700A is shown in FIG. 13 wherein the samereference numbers refer to the same or similar structure. A concaveelement 702A, which may be 2-3 concave elements 702A. The manipulator700A has a first loop 704A with a first leg 714A and second leg 716A. Afirst end 708 a of the concave element 702A may be integrally formedwith the loop 704A while the second end 710A may be independentlymovable within a lumen 712A. The loop 704A and the concave element 702Amay be made of ribbon-shaped material having a width to thickness ratioof more than 3 to 1 to create a more closed basket 706A compared to wirehaving a 1 to 1 ratio. Referring to FIG. 14, another tissue manipulator700B is shown wherein the same or similar reference number refer to thesame or similar structure. The manipulator 700B has a first loop 704Bwith a concave element 702B being a net 703. The net 703 may beintegrally formed or a separate element attached to the loop 704B.

Referring to FIG. 15, another tissue manipulator 700C is shown whereinthe same or similar reference number refer to the same or similarstructure. The manipulator 700C has a first loop 704C with a concaveelement 702C, which may be 2-3 concave elements 702C, integrally formedat first end 708C and may have a second end 710C independently movablewithin a lumen 712C within shaft 713C. or a separate element attached tothe loop 704B. The manipulator 700C is free of interconnecting elementsbetween any two sides of the loop and may also include nointerconnecting elements between the concave elements 702C.

Referring to FIGS. 16 and 17, another tissue manipulator 700D is shownin FIG. 16 wherein the same reference numbers refer to the same orsimilar structure. The tissue manipulator 700D has a first loop 708D anda second loop 708 E with corresponding concave elements 708D and 708E,respectively. A first basket 706D and a second basket 706E are movablebetween a nested position of FIG. 17 and a position in which the twobaskets oppose one another as shown in FIG. 16.

Referring to FIG. 12 again, the tissue manipulator 700 is describedfurther and it is understood that all aspects described here areapplicable to all of the other tissue manipulators 700A-D and areexpressly incorporated for each. The loop 704 has an unbiased shapewhich bounds an area defined in an orientation OA that maximizes thearea. The area has an effective diameter which is equal to the diameterof a circle having the same area. The first loop 704 moves toward theunbiased shape when moving from the collapsed position to the expandedposition. The first loop 704 may have effective diameter of 4.5 mm to6.5 mm or 5.0 mm to 6.0 mm. Of course, the various aspects of theinvention may be carried out with different sizes. As used herein, the“area” of the loop is determined by the orientation OA which maximizesthe area. The first loop is expanded with the first loop orientationbeing within 45 degrees of perpendicular to a longitudinal axis LA at adistal end of the shaft 713.

Referring again to FIG. 13, a rotating cutter 740 is shown which may beused with any of the device and methods described herein. The rotatingcutter 740 has a cutting element 742 at a distal end 744 which may be aseries of teeth 746, a sharpened edge, ridges spikes or any othersuitable shape. Rotating as used herein may mean rotation in onedirection and then back in the other without departing from the scope ofthe invention. The rotating cutter 740 may be independently positionedand moved for use as desired or may be fixed in a working position shownby dotted-line working position 750. The rotating cutter 740 is recessedfrom the distal end 751 of the shaft 713A when in the working position750 so that the rotating cutter 740 is not exposed from an opening 754at the distal end 744. The tissue manipulating devices of the presentinvention may be used to push, draw, squeeze or otherwise manipulatetissue into engagement with the rotating cutter 740. The rotating cutter740 may further have a suction lumen 752 therein for suctioningmaterial.

Referring now to FIGS. 18A-18D and 19, a cutting device 800 for cuttingmaterial in the eye and, in a specific application, for cutting a wholelens while contained within a capsular bag is shown. The cutting device800 has a shaft 802 with a first shaft part 804 and a second shaft part806 which are movable relative to one another between a first positionof FIG. 18A and a second position of FIG. 19. An elongate element 808has a first end 810 coupled to the first shaft part 804 and a second end812 coupled to the second shaft part 806. The cutting device 800 forms aloop 814 with at least part of the elongate element 808 forming the loop814 together with the shaft 802. The loop 814 moves from a collapsedposition of FIG. 18A to an expanded position of FIG. 19 when the firstand second shaft parts 804, 806 move from the first position to thesecond position. The loop 814 may be expanded to advance the loop 814between the capsular bag and the whole lens. Material is positioned inan open area 813 of the loop 814 and then cut by collapsing the loop804.

The elongate element 808 expands in a manner which facilitates cuttingthe whole lens within the capsular bag. The elongate element 808 mayhave a first flexible portion 820 and optionally a second flexibleportion 822 with an intermediate portion 824 therebetween. The elongateelement 808 initially expands laterally outward as shown in FIG. 18C.When the first and second flexible portions 820, 822 begin to bend, theloop 814 has a proximal portion 826 and a distal portion 828 whichextend proximally and distally, respectively, from the intermediateportion 824. The flexible portion may be at least 1.5 more stiff inbending than the intermediate portion. Furthermore, the elongate element808 may be in an unbiased position when collapsed as shown in FIG. 18Awith the elongate element 808 being deformed to deflect and expand theloop. Of course, the elongate element 808 may also have a preset shapewhich facilitates movement to the expanded position while requiring lessforce to deform the elongate element 808.

Referring now to FIGS. 20A-C and 21A-B, another cutting device 900 isshown for cutting material in the eye and, in a specific application,for cutting a whole lens WL within a capsular bag CB through an openingOP (such as a capsulorhexis) that exposes an anterior surface of thelens (see FIG. 19). A shaft 902 has a first shaft part 904 and a secondshaft part 906 movable relative to one another between the position ofFIG. 20A and FIG. 21B so that a loop 908 formed by the device 902 movesfrom a collapsed position to an expanded position. An elongate element910 has a first end 912 coupled to the first shaft part 904 and a secondend 914 coupled to the second shaft part 906. The loop 908 is formed atleast in part by the elongate element 910 with the loop 908 also beingformed by a portion of the shaft 902.

The loop 908 is expanded so that the first end 912 has a longitudinalorientation LFE that changes by an angle CA at least 120 degrees withrespect to the shaft 902 adjacent to the second end 914 of the elongateelement 910 when the first and second shaft parts 904, 906 move from thefirst position to the second position. FIG. 21A shows the angle CA beingabout 180 degrees.

The 902 shaft may also include a flexible distal end 920 with the firstend 912 of the elongate element 910 coupled to the flexible distal end920 of the shaft 902. The flexible distal end 920 of the shaft 902 maycontribute to the changing orientation of the first end 912 with respectto the longitudinal orientation of the shaft 902 adjacent the second end914. The flexible distal end 920 may change in orientation by an angleCO of at least 30 degrees when the first and second shaft parts movefrom the first position to the second position.

The first end 912 of the elongate element 912 may be have a pinnedconnection so that the first end 912 rotates relative to the first shaftpart 904 for an angle of at least 120 degrees and may be for 180degrees+/−45 degrees when the first and second shaft parts move from thefirst position to the second position. The loop 908 has a distal portion930 that advances distally beyond a distal end of the shaft 902 as theloop 908 moves from the collapsed position to the expanded position. Thefirst end 912 of the elongate element changes orientation so that theloop 908 advances distally beyond a distal end of the shaft 902 as theloop 908 moves from the collapsed position to the expanded position. Thesecond end 914 may also have a rotatable connection 932, such as apinned connection 934, to the second shaft part 906. The second end 914may rotate and change in orientation relative to the shaft adjacent thesecond end by 90 degrees+/−45 degrees when the first and second shaftparts 904, 906 move from the first position to the second position. Theelongate element 912 may be in an unbiased position in FIG. 20A with theelongate element 912 deformed into the positions of FIG. 21A and FIG.21B. Of course, the elongate element 912 may also have a preset shapesimilar to FIG. 21B without departing from the scope of the invention.

Use of and discussion of all aspects of the first flexible portion orthe first end are equally applicable to the second end and arespecifically incorporated herein. Furthermore, a mixture of first endand second end are also expressly incorporated such as a flexible firstend and a rotatable second end or the reverse. The elongate element maybe without a preset shape although numerous aspects of the presentinvention may be practiced with a wholly or partially preset shape. Theelongate element may not include a superelastic material in this andother embodiments which may reduce the cost of the device. The loopmoves from an unbiased position toward a biased position, and anincreasing the bias or load on the elongate element, when moving fromthe collapsed position to the expanded position.

Use of the terms “first” and “second” are used with reference to eachspecific application, however, the terms are interchangeable and, thus,the claims may define an aspect as the “second” even though it isdescribed as the “first” elsewhere without departing from the scope ofthe invention. For example, the terms first and second may simply beinterchanged. In another example, the “first” may be omitted so that the“second” becomes the “first.”

Although embodiments of various methods and devices are described hereinin detail with reference to certain versions, it should be appreciatedthat other versions, embodiments, methods of use, and combinationsthereof are also possible within the scope of the invention. Therefore,the spirit and scope of the invention should not be limited to thedescription of the embodiments contained herein. Furthermore, althoughthe various embodiments and description may specify certain anatomicallocations, species, or surgical procedures, it should be appreciatedthat these embodiments apply to other locations, species, and surgicalprocedures. For example, the device may include a remote suction sourcewhile still providing for purging of the suction path. The device alsoincludes no powered elements but a pneumatic source of power(pressurized canister) or a battery may be used without departing fromnumerous aspects of the present invention. Thus, as it can be seen, theinvention has been described with respect to various independentaspects.

What is claimed is:
 1. A device for removing material in a medicalprocedure, comprising: a shaft having a lumen, the lumen extendingthrough the shaft to an opening; a suction source; a suction pathextending from the suction source to the opening and including thelumen, material is suctioned into the opening and through the lumenalong the suction path by the suction source in use.
 2. The device ofclaim 1, further comprising: a disposal enclosure coupled to the suctionpath to receive material from the suction path.
 3. The device of claim1, further comprising: an actuator positioned along the suction path,the actuator being operable by the user to an open position whichexposes the opening to the suction source and a closed position whichisolates the opening from the suction source.
 4. The device of claim 1,wherein: the actuator is movable to a first open position and a secondopen position, the first open position providing a different magnitudeof suction than the second open position.
 5. The device of claim 1,wherein: the actuator is continuously variable between the firstposition and the second position to provide a continuously variablemagnitude of suction selected by the user.
 6. The device of claim 1,wherein: the lumen has a deformable portion defining a portion of thesuction path; the actuator engaging the deformable portion of thesuction path.
 7. The device of claim 1, wherein: the deformable portionof the suction path is variably deformable between the first positionand the second position.
 8. The device of claim 1, further comprising: avalve positioned between the disposal enclosure and the suction path,the valve permitting material to move from the suction path to thedisposal enclosure when open and isolating the disposal enclosure fromthe suction path when closed.
 9. The device of claim 1, wherein: thevalve is a one-way valve positioned between the disposal enclosure andthe suction path which permits material to move from the suction path tothe disposal enclosure, the one-way valve isolating the disposalenclosure from the suction path when the suction source applies suctionto draw material into the opening and through the suction path.
 10. Thedevice of claim 1, wherein: the disposal enclosure is isolated from thesuction path when the suction source draws material into the opening,the disposal enclosure being isolated so that the disposal enclosure isnot under the influence of suction pressure from the suction path whenthe suction source draws material into the opening.
 11. The device ofclaim 1, further comprising: the disposal enclosure is configured to besupported independently, the disposal enclosure having a disposal lumenextending from the suction path to the disposal enclosure.
 12. Thedevice of claim 1, wherein: the suction path is entirely hand-held 13.The device of claim 1, wherein: the suction path is more than halfnon-manually deformable.
 14. The device of claim 1, wherein: the suctionpath is at least 90% non-manually deformable.
 15. The device of claim 1,wherein: the suction path has a length of less than 20 cm.
 16. Thedevice of claim 1, wherein: the suction path has a volume of no morethan 25 ml.
 17. The device of claim 1, wherein: the suction path has avolume of no more than 15 ml.
 18. The device of claim 1, furthercomprising: an actuator positioned along the suction path, the actuatorbeing movable between an open position which and a closed position, theclosed position preventing flow through the suction path; the suctionpath having a proximal volume proximal to the actuator and a distalvolume distal to the actuator, the distal volume being less than 2 ml.19. The device of claim 1, wherein: the proximal volume is less than 25ml.
 20. The device of claim 1, wherein: the lumen is sized forintroduction into the eye, the shaft having a longitudinal axis with across-sectional area of no more than 0.8 mm(2) measured from an outerdiameter the shaft, the lumen having a cross-sectional area of at least0.28 mm(2).
 21. The device of claim 1, wherein: the suction source is amovable element which is displaced in a direction to draw the materialinto the opening and through the suction path.
 22. The device of claim1, wherein: the movable element is displaced in an opposite direction tothe direction to move material in the suction path into the disposalenclosure.
 23. The device of claim 1, wherein: the movable element ispart of hand held unit.
 24. The device of claim 1, wherein: the suctionsource is hand-held.
 25. The device of claim 1, wherein: the suctionsource includes no electronic control and no electric powered parts. 26.The device of claim 1, wherein: a power source coupled to the suctionsource, the power source being powered by the user.
 27. The device ofclaim 26, wherein: the power source is a compressed spring which iscompressed by the user
 28. The device of claim 1, wherein: the device ismanually purged.
 29. The device of claim 1, further comprising: apurging mechanism coupled to the suction path, the purging mechanismmoving the material from the suction path to the disposal enclosure. 30.The device of claim 29, wherein: the purging mechanism moves thematerial through the suction path in an opposite direction to suction ofmaterial along the suction path.
 31. The device of claim 29, wherein:the purging mechanism has a movable element; and the suction device alsoincluding the movable element to create suction pressure in the suctionpath.
 32. The device of claim 31, wherein: the movable element iscoupled to a spring to load the movable element with a spring load. 33.The device of claim 31, wherein: the movable element is spring loaded bythe user.
 34. The device of claim 31, wherein: the movable element ismanually spring loaded by the user.
 35. The device of claim 1, furthercomprising: a disposal enclosure; means for purging the suction path,the purging means moving material in the suction path distally whenmoving the material in the suction path to the disposal enclosure. 36.The device of claim 1, wherein: the suction source is a bellows.
 37. Thedevice of claim 36, wherein: the bellows are compressed with a foot ofthe user.
 38. The device of claim 36, wherein: the bellows arecompressed to move material in the suction path into a disposalenclosure.
 39. The device of claim 36, wherein: the bellows arecompressed to move material within the bellows into the disposalenclosure.
 40. The device of claim 1, wherein: the suction source is abladder.
 41. The device of claim 40, wherein: the bladder is deformedmanually by the user.
 42. The device of claim 40, wherein: the bladderis compressed manually by the user, wherein compression is manuallymaintained on the bladder to stop suction, wherein reducing compressionon the bladder produces suction to suction the material into theopening.
 43. The device of claim 40, wherein: the bladder is moved froman unbiased stated to a compressed state, the user releasing compressingfrom the compressed state to begin suctioning material into the opening.44. The device of claim 40, further comprising: a disposal enclosurecoupled to the suction path; the bladder being coupled to a disposalenclosure so that movement of the bladder from the unbiased state to thecompressed state moves the material in the suction path into thedisposal enclosure.
 45. The device of claim 1, wherein: the suctionsource is a venturi.
 46. The device of claim 45, wherein: the suctionsource include a source of pressurized gas, the source of pressurizedgas being hand-held.
 47. The device of claim 45, further comprising: adisposal enclosure; the venture directs the source of pressurized gasinto the disposal enclosure together with material in the suction path.48. The device of claim 1, further comprising: an irrigation lumenhaving an irrigation outlet.
 49. A method of aspirating an eye during aprocedure on the eye, comprising: introducing a lumen of a device intoan eye, the lumen having an opening positioned in the eye, the devicealso having a suction path from a suction source to the opening in thelumen; and exposing the opening to suction pressure from the suctionsource so that material in the eye enters the opening under theinfluence of the suction source, the material being drawn along thesuction path by the suction source, the suction path defining a suctionvolume under the influence of the suction pressure by the suctionsource.
 50. The method of claim 49, wherein: the exposing is carried outwith an actuator positioned along the suction path, the actuator beingoperable by the user to an open position which exposes the opening tothe suction source and a closed position which isolates the opening fromthe suction source.
 51. The method of claim 49, wherein: the exposing iscarried out with the actuator being movable to a first open position anda second open position, the first open position providing a differentmagnitude of suction than the second open position.
 52. The method ofclaim 49, wherein: the exposing is carried out with the actuator beingcontinuously variable between the first position and the second positionto provide a continuously variable magnitude of suction selected by theuser.
 53. The method of claim 49, wherein: the exposing is carried outwith the actuator engaging a deformable portion of the suction path. 54.The method of claim 49, wherein: the exposing is carried out with thedeformable portion of the suction path being variably deformable betweenthe first position and the second position.
 55. The method of claim 49,wherein: the exposing is carried out with the suction path having adistal volume which is distal to the actuator of less than 2 ml.
 56. Themethod of claim 49, wherein: the exposing is carried out with thesuction path having a proximal volume of less than 25 ml which isproximal to the actuator and between the suction source and theactuator, the proximal volume being a minimum working volume.
 57. Themethod of claim 49, wherein: the introducing is carried out with thedevice also including a disposal enclosure coupled to the suction pathto receive material from the suction path.
 58. The method of claim 49,wherein: the introducing is carried out with a valve positioned betweenthe disposal enclosure and the suction path, the valve permittingmaterial to move from the suction path to the disposal enclosure whenopen and isolating the disposal enclosure from the suction path whenclosed.
 59. The method of claim 49, wherein: the introducing is carriedout with the valve being a one-way valve positioned between the disposalenclosure and the suction path, the one-way valve permitting material tomove from the suction path to the disposal enclosure.
 60. The method ofclaim 49, wherein: the introducing is carried out with the disposalenclosure being isolated from the suction path when the suction sourcedraws material into the opening, the disposal enclosure being isolatedso that the disposal enclosure is not under the influence of suctionpressure from the suction path when the suction source draws materialinto the opening.
 61. The method of claim 49, wherein: the introducingis carried out with the device having a disposal enclosure configured tobe supported independently, the disposal enclosure having a disposallumen extending from the suction path to the disposal enclosure.
 62. Themethod of claim 49, wherein: the introducing is carried out with thedevice having the suction path is entirely hand-held
 63. The method ofclaim 49, wherein: the introducing is carried out with the device havingthe suction path is more than half non-manually deformable.
 64. Themethod of claim 49, wherein: the introducing is carried out with thedevice having the suction path is at least 90% non-manually deformable.65. The method of claim 49, wherein: the introducing is carried out withthe device having the suction path having a length of less than 20 cm.66. The method of claim 49, wherein: the introducing is carried out withthe device having the suction path has a volume of less than 25 ml. 67.The method of claim 49, wherein: the introducing is carried out with thedevice having the suction path has a volume of less than 15 ml.
 68. Themethod of claim 49, wherein: the introducing is carried out with thedevice having a proximal volume under the influence of suction pressureby the suction source proximal to the actuator when the actuator is inthe closed position, the proximal suction volume having a volume of lessthan 25 ml.
 69. The method of claim 49, wherein: the introducing iscarried out with the device having a proximal volume under the influenceof suction pressure by the suction source when the actuator is in theclosed position, the proximal suction volume less than 25 ml.
 70. Themethod of claim 49, wherein: the introducing is carried out with thelumen being sized for introduction into the eye, the shaft having anouter perimeter having a cross-sectional area of no more than 0.8 mm(2),the lumen having a cross-sectional area of at least 0.28 mm(2).
 71. Themethod of claim 49, wherein: the introducing is carried out with thesuction source including a movable element which is displaced in adirection to draw the material into the opening and proximally along thesuction path.
 72. The method of claim 49, wherein: the introducing iscarried out with the movable element being displaceable in an oppositedirection to the direction to move material in the suction path into thedisposal enclosure.
 73. The method of claim 49, wherein: the introducingis carried out with the movable element being part of a hand held unit.74. The method of claim 49, wherein: the introducing is carried out withthe device having the suction source is a hand-held unit.
 75. The methodof claim 49, wherein: the introducing is carried out with the suctionsource having no electronic control and no electric powered parts. 76.The method of claim 49, wherein: the introducing is carried out with thedevice having a power source which is powered by the user.
 77. Themethod of claim 76, wherein: the introducing is carried out with thepower source being a compressed spring which is compressed by the user.78. The method of claim 49, further comprising: purging the fluid pathby moving the material into the disposal enclosure.
 79. The method ofclaim 78, wherein: the purging is carried out independent of suctioning.80. The method of claim 49, wherein: the purging is carried out with thedevice being manually purged.
 81. The method of claim 49, wherein: thepurging is carried out with the device having a purging mechanismcoupled to the suction path, the purging mechanism moving the materialfrom the suction path to the disposal enclosure.
 82. The method of claim49, wherein: the purging is carried out with the device moving thematerial through the suction path in an opposite direction to suction ofmaterial along the suction path.
 83. The method of claim 82, wherein:the purging is carried out with a purging mechanism having a movableelement.
 84. The method of claim 83, wherein: the exposing is carriedout with the suction device also including the movable element to createsuction pressure in the suction path.
 85. The method of claim 83,wherein: the exposing is carried out with the movable element beingcoupled to a spring to load the movable element with a spring load. 86.The method of claim 85, wherein: the exposing is carried out with themovable element being spring loaded by the user.
 87. The method of claim83, wherein: the exposing is carried out with the movable element beingmanually spring loaded by the user to create suction pressure along thesuction path.
 88. The method of claim 49, wherein: the exposing iscarried out with the suction source being a bellows.
 89. The method ofclaim 88, wherein: the exposing is carried out with the bellows beingcompressed with a foot of the user.
 90. The method of claim 88, wherein:the exposing is carried out with the bellows being compressed to movematerial in the suction path into a disposal enclosure.
 91. The methodof claim 88, wherein: the exposing is carried out with the bellows beingcompressed to move material within the bellows into the disposalenclosure.
 92. The method of claim 49, wherein: the exposing is carriedout with the suction source being a bladder.
 93. The method of claim 92,wherein: the exposing is carried out with the bladder being deformedmanually by the user and hand-held.
 94. The method of claim 92, wherein:the exposing is carried out with the bladder being compressed by theuser, wherein compression is maintained on the bladder to stop suction,wherein reducing compression on the bladder produces suction to suctionthe material into the opening.
 95. The method of claim 92, wherein: theexposing is carried out with the suction source including a bladderwhich is movable from an unbiased stated to a compressed state, the userreleasing compression from the compressed state to begin suctioningmaterial into the opening.
 96. The method of claim 92, wherein: theexposing is carried out with the bladder being coupled to a disposalenclosure so that movement of the bladder from the unbiased state to thecompressed state moves the material in the suction path into thedisposal enclosure.
 97. The method of claim 49, wherein: the exposing iscarried out with the suction source being a venturi.
 98. The method ofclaim 97, wherein: the exposing is carried out with the suction sourceincluding a source of pressurized gas, the source of pressurized gasbeing hand-held.
 99. The method of claim 97, wherein: the exposing iscarried out with the venturi directing the source of pressurized gas toa disposal enclosure together with material in the suction path. 100.The method of claim 49, further comprising: irrigating the eye throughan irrigation lumen having an irrigation outlet.
 101. A suction tip fora suction device used to suction material from an eye, comprising; ashaft; a lumen extending through the shaft; a distal opening in theshaft, the distal opening having an area which is defined by an openingaxis which maximizes a size of the opening, the opening area defining aneffective diameter defined as the diameter equivalent to a circle havingthe same size as the opening area; and a restrictor extending over thedistal opening when viewed along the opening axis.
 102. The suction tipof claim 101, wherein: the restrictor has a support arm extending fromthe distal end of the shaft.
 103. The suction tip of claim 101, wherein:the restrictor has a stop attached to the support arm, the stop beingspaced apart from the distal opening and positioned over the distalopening when viewed along the opening axis
 104. The suction tip of claim101, wherein: the restrictor is spaced apart from the distal opening0.80 to 1.10 times the effective diameter along the opening axis andaligned with the distal opening when viewed along the opening axis. 105.The suction tip of claim 101, wherein: the restrictor is spaced apartfrom the distal opening 0.85 to 1.00 times the effective diameter. 106.The suction tip of claim 101, wherein: the restrictor has a distal endthat extends no more than 1.5 times the effective diameter from thedistal opening measured along the opening axis from the distal opening.107. The suction tip of claim 101, wherein: the restrictor has an areaof when viewed along the opening axis, the area of the restrictor being0.1 to 1.2 times the opening area of the distal opening when viewedalong the opening axis.
 108. The suction tip of claim 101, wherein: therestrictor has a support arm extending from the distal end, the supportarm having an angular extent when viewed along the opening axis of nomore than 90 degrees, the distal opening being free of obstruction apartfrom the support arm between the distal opening and the restrictor whenviewed along the opening axis.
 109. The suction tip of claim 101,wherein: the restrictor forms a feed opening leading to the distalopening, the feed opening defining a surface extending between anddefined by the restrictor and the distal end of the shaft
 110. Thesuction tip of claim 101, wherein: the restrictor forms the feed openingwith the surface being an elongate surface with a length of 2.5-3.5times the effective diameter.
 111. The suction tip of claim 101,wherein: the restrictor forms the feed opening with the surface having awidth of 0.8 to 1.1 times the effective diameter.
 112. The suction tipof claim 101, wherein: the restrictor has a support arm that is movablycoupled to the shaft.
 113. The suction tip of claim 101, wherein: thesupport arm is longitudinally movable relative to the shaft to adjust alongitudinal position of the support arm, the support arm being movablefrom a working position to a displaced position, the working positionbeing a position used when suctioning material into the distal opening.114. The suction tip of claim 101, wherein: the restrictor is formedwith the support arm having the displaced position being longitudinallydisplaced relative to the working position.
 115. The suction tip ofclaim 101, wherein: the shaft has a longitudinal axis: and therestrictor is formed with the support arm rotating relative to thelongitudinal axis of the support shaft when in the displaced position.116. The suction tip of claim 101, wherein: the restrictor is formedwith the displaced position being longitudinally displaced to move thesupport shaft in a proximal direction toward the distal opening. 117.The suction tip of claim 101, wherein: the restrictor is formed so thatthe displaced position moves material between the restrictor and thedistal opening toward the distal opening.
 118. The suction tip of claim101, wherein: the restrictor is mounted over the shaft and islongitudinally slidable relative to the shaft, the restrictor beingmovable to a stored position in which the entire restrictor ispositioned proximal to the distal opening.
 119. The suction tip of claim118, wherein: the restrictor is deformed when in the stored position120. The suction tip of claim 118, wherein: the restrictor has a livinghinge which is deformed when the restrictor is in the stored position.121. The suction tip of claim 120, wherein: the restrictor has a supportarm which forms at least part of the living hinge.
 122. The suction tipof claim 101, wherein: the restrictor is longitudinally movable to aposition which is at least two effective diameters of the distal openingmeasured along an orientation that maximizes an area of the distalopening.
 123. A method of suctioning material from an eye, comprising;positioning a distal end of shaft within an eye, the shaft having alumen extending through the shaft, the shaft also having a distalopening in the shaft, the distal opening having an area which is definedby an opening axis having an orientation which maximizes a size of theopening, the opening area defining an effective diameter which isdefined as the diameter equivalent of an equivalent circle having theopening area, wherein a restrictor extends over the distal opening whenviewed along the opening axis in a working position; and suctioningmaterial into the distal opening and through the lumen.
 124. The methodof claim 123, wherein: suctioning is carried out with the restrictorhaving a support arm extending from the distal end of the shaft. 125.The method of claim 123, wherein: the suctioning is carried out with therestrictor having a stop attached to the support arm, the stop beingspaced apart from the distal opening and positioned over the distalopening when viewed along the opening axis.
 126. The method of claim123, wherein: the suctioning is carried out with the restrictor spacedapart from the distal opening 0.80 to 1.10 times the effective diameteralong the opening axis and aligned with the distal opening along theopening axis in the working position.
 127. The method of claim 123,wherein: the suctioning is carried out with the restrictor being spacedapart from the distal opening 0.85 to 1.00 times the effective diameterin the longitudinal direction and longitudinally aligned with the distalopening in the working position.
 128. The method of claim 123, wherein:the suctioning is carried out with the restrictor having a distal endthat extends no more than 1.5 times the effective diameter from thedistal opening measured along the opening axis from the distal openingin the working position.
 129. The method of claim 123, wherein: thesuctioning is carried out with the restrictor having an area when viewedalong the opening axis, the area of the restrictor being 0.1 to 1.2times the opening area of the distal opening in the working position.130. The method of claim 123, wherein: the suctioning is carried outwith the restrictor having a support arm extending from the distal end,the support arm having an angular extent when viewed along the openingaxis of no more than 90 degrees, the distal opening being free ofobstruction apart from the support arm between the distal opening andthe restrictor in the working position.
 131. The method of claim 123,wherein: the suctioning is carried out with the restrictor forming afeed opening leading to the distal opening, the feed opening defining asurface extending between the restrictor and the distal end of theshaft.
 132. The method of claim 123, wherein: the suctioning is carriedout with the restrictor forming the feed opening with the surface beingan elongate surface with a length of 2.5-3.5 times the effectivediameter.
 133. The method of claim 123, wherein: the suctioning iscarried out with the restrictor forming the feed opening with thesurface having a width of 0.8 to 1.1 times the effective diameter. 134.The method of claim 123, wherein: the suctioning is carried out with therestrictor having a support arm that is movably coupled to the shaft.135. The method of claim 123, wherein: the suctioning is carried outwith the support arm being longitudinally movable relative to the shaftto adjust a longitudinal position of the support arm, the support armbeing movable from the working position to a displaced position, theworking position being a position used when suctioning material into thedistal opening.
 136. The method of claim 123, wherein: the suctioning iscarried out with the restrictor being formed with the support arm beingmovable to a displaced position which is longitudinally displacedrelative to the working position.
 137. The method of claim 123, wherein:the suctioning is carried out with the shaft having a longitudinal axis,the restrictor being formed with the support arm being rotatablerelative to the longitudinal axis of the support shaft.
 138. The methodof claim 123, wherein: the suctioning is carried out with the restrictorbeing longitudinally movable to move the support shaft in a proximaldirection toward the distal opening.
 139. The method of claim 123,further comprising: displacing the restrictor toward the distal openingto move material toward the distal opening.
 140. The method of claim123, further comprising: displacing the restrictor longitudinallyrelative to the shaft, the restrictor being mounted over the shaft andbeing longitudinally slidable relative to the shaft, the restrictorbeing movable to a stored position in which the entire restrictor ispositioned proximal to the distal opening.
 141. The method of claim 123,further comprising: storing the restrictor in a stored position, therestrictor being deformed when in the stored position.
 142. The methodof claim 141, wherein: the storing is carried out with the restrictorhaving a living hinge which is deformed by the shaft when the restrictoris in the stored position.
 143. The method of claim 141, wherein: thestoring is carried out with the restrictor having a support arm whichforms at least part of the living hinge.
 144. The method of claim 123,further comprising: displacing the restrictor longitudinally to aposition which is at least two effective diameters from the distalopening measured along an orientation that maximizes an area of thedistal opening.
 145. A tissue manipulator a shaft having a lumen with adistal opening; a first loop having a first leg and a second leg, atleast one of the first and second legs extending through the lumen, thefirst loop being movable from a collapsed position to an expandedposition when the at least one of the first and second legs is advancedthrough the lumen and out the distal opening in the lumen; and a secondloop having a first leg and a second leg, at least one of the first andsecond legs extending through the lumen, the second loop being movablefrom a collapsed position to an expanded position when the at least oneof the first and second legs is advanced through the lumen and out thedistal opening in the lumen.
 146. The tissue manipulator of claim 145,wherein: the shaft is sized for introduction of a distal end of theshaft into any eye.
 147. The tissue manipulator of claim 145, wherein:the first loop has an unbiased shape, wherein the unbiased shape of thefirst loop bounds an area defined in an orientation that maximizes thearea, the area having an effective diameter which is equal to thediameter of a circle having the area, the first loop moving toward theunbiased shape when moving from the collapsed position to the expandedposition.
 148. The tissue manipulator of claim 145, wherein: theeffective diameter of the area of the first loop is 4.5 mm to 6.5 mm.149. The tissue manipulator of claim 145, wherein: the effectivediameter of the area of the first loop is 5.0 mm to 6.0 mm.
 150. Thetissue manipulator of claim 145, wherein: the first loop has aneffective diameter of the expanded position being 4.5 to 6.5 mm. 151.The tissue manipulator of claim 145, wherein: the first loop has aneffective diameter of the expanded position being 5.0 to 6.0 mm. 152.The tissue manipulator of claim 145, wherein: the effective diameter ofthe unbiased shape of the second loop being within 20% of an effectivediameter of the expanded position of the second loop.
 153. The tissuemanipulator of claim 145, wherein: the second loop has an unbiasedshape, wherein the unbiased shape of the second loop bounds an areadefined in an orientation that maximizes the area, the area having aneffective diameter which is equal to the diameter of a circle having thearea, the second loop moving toward the unbiased shape when moving fromthe collapsed position to the expanded position.
 154. The tissuemanipulator of claim 145, wherein: the effective diameter of the area ofthe second loop is 4.5 mm to 6.5 mm.
 155. The tissue manipulator ofclaim 145, wherein: the effective diameter of the area of the secondloop is 5.0 mm to 6.0 mm.
 156. The tissue manipulator of claim 145,wherein: the effective diameter of the unbiased shape of the second loopbeing within 20% of an effective diameter of the expanded position ofthe second loop.
 157. The tissue manipulator of claim 145, wherein: theshaft has a longitudinal axis at a distal end of the shaft; the firstloop has an orientation which maximizes an area of the first loop whenin the expanded position when viewed along the orientation, theorientation being within 45 degrees of perpendicular to the longitudinalaxis.
 158. The tissue manipulator of claim 145, wherein: the shaft has alongitudinal axis at a distal end of the shaft; the second loop has anorientation which maximizes an area of the second loop when in theexpanded position when viewed along the orientation, the orientationbeing within 45 degrees of perpendicular to the longitudinal axis. 159.The tissue manipulator of claim 145, wherein: the first loop is spacedapart from the second loop to define a volume therebetween when thefirst and second loops are in the expanded position, the volumetherebetween being 0.48 mm(3) to 0.84 mm(3).
 160. The tissue manipulatorof claim 145, wherein: an intermediate element positioned between thefirst loop and the second loop.
 161. The tissue manipulator of claim145, wherein: the intermediate element is a third loop positionedbetween the first loop and the second loop.
 162. The tissue manipulatorof claim 145, wherein: the intermediate element includes aninterconnecting element extending between the first loop and the secondloop.
 163. The tissue manipulator of claim 145, wherein: theinterconnecting element of the intermediate element is integrally formedwith the first loop and the second loop.
 164. The tissue manipulator ofclaim 145, wherein: the interconnecting element is a flexible filamentextending between the first loop and the second loop.
 165. The tissuemanipulator of claim 145, wherein: the third loop formed by theintermediate element has a first leg and a second leg, at least one ofthe first and second legs extending through the lumen, the third loopbeing movable from a collapsed position to an expanded position when theat least one of the first and second legs is advanced through the lumenand out the distal opening in the lumen.
 166. The tissue manipulator ofclaim 145, wherein: the third loop has an unbiased shape, wherein theunbiased shape of the third loop bounds an area defined in anorientation that maximizes the area, the area having an effectivediameter which is equal to the diameter of a circle having the area, thethird loop moving toward the unbiased shape when moving from thecollapsed position to the expanded position.
 167. The tissue manipulatorof claim 145, wherein: the effective diameter of the area of the thirdloop is 4.5 mm to 6.5 mm.
 168. The tissue manipulator of claim 145,wherein: the effective diameter of the area of the third loop is 5.0 mmto 6.0 mm
 169. The tissue manipulator of claim 145, wherein: the shafthas a longitudinal axis at a distal end of the shaft; the third loop hasan orientation which maximizes an area of the first loop when in theexpanded position when viewed along the orientation, the orientationbeing within 30 degrees of perpendicular to the longitudinal axis. 170.The tissue manipulator of claim 145, wherein: the third loop isconfigured to cut material contained within the third loop when thethird loop moves from the expanded position toward the collapsedposition.
 171. The tissue manipulator of claim 145, wherein: the firstloop and the second loop defining an exposed surface between the firstloop and the second loop when the first and second loops are both in theexpanded position.
 172. The tissue manipulator of claim 145, wherein:the exposed surface between the first loop and the second loop has anarea of 15 mm(3) to 60 mm(3).
 173. The tissue manipulator of claim 145,wherein: the first loop has an unbiased shape, wherein the unbiasedshape of the first loop bounds an area defined by an orientation thatmaximizes the area, the area having an effective diameter which is equalto the diameter of a circle having the area, the first loop movingtoward the unbiased shape when moving from the collapsed position to theexpanded position; and the exposed surface between the first loop andthe second loop is 3-10 times the effective diameter.
 174. The tissuemanipulator of claim 145, wherein: the exposed surface between the firstloop and the second loop having 2-8 independent cells.
 175. The tissuemanipulator of claim 145, wherein: the exposed surface between the firstloop and the second loop having 2-6 independent cells.
 176. The tissuemanipulator of claim 145, wherein: the exposed surface between the firstloop and the second loop having 2-4 independent cells.
 177. The tissuemanipulator of claim 145, wherein: the exposed surface between the firstloop and the second loop having 2 independent cells.
 178. The tissuemanipulator of claim 145, wherein: the exposed surface has an area whichis at least 4 times larger than an area of the intermediate elementpositioned between the first loop and the second loop when the exposedsurface is viewed radially inward with respect to the first and secondloops.
 179. The tissue manipulator of claim 145, wherein: the first loophas at least 80% of the loop being 1.5-3.5 mm from the second loop. 180.The tissue manipulator of claim 145, wherein: the first loop isconfigured to cut material contained within the first loop when thefirst loop moves from the expanded position toward the collapsedposition.
 181. The tissue manipulator of claim 145, wherein: the secondloop is configured to cut material contained within the first loop whenthe first loop moves from the expanded position toward the collapsedposition.
 182. The tissue manipulator of claim 145, further comprising:a first support element extending from a distal end of the shaft whenthe first loop is in the expanded position, the first support elementbeing an elongate element that extends to a free end.
 183. The tissuemanipulator of claim 145, wherein: the first support element ispositioned with the free end positioned within an area of the first loopwhen viewing the first loop along an orientation that maximizes the areaof the first loop.
 184. The tissue manipulator of claim 145, wherein:the first loop has an effective diameter when in the expanded position,the effective diameter being a diameter of a circle having the area ofthe first loop in the expanded position; and the first support elementextends into the area of the first loop so that the free end ispositioned 0.05 to 0.30 times the effective diameter of the first loop.185. The tissue manipulator of claim 145, further comprising: a secondsupport element extending from a distal end of the shaft when the secondloop is in the expanded position, the second support element being anelongate element that extends to a free end.
 186. The tissue manipulatorof claim 145, wherein: the second support element is positioned with thefree end positioned within an area of the second loop when viewing thesecond loop along an orientation that maximizes the area of the secondloop.
 187. The tissue manipulator of claim 145, wherein: the second loophas an effective diameter when in the expanded position, the effectivediameter being a diameter of a circle having the area of the second loopin the expanded position; and the second support element extends intothe area of the second loop so that the free end is positioned 0.05 to0.30 times the effective diameter of the second loop.
 188. The tissuemanipulator of claim 145, further comprising: the first loop having atleast one interconnecting element extending from a first connection tothe first loop to a second connection to the first loop; the second loophaving at least one interconnecting element extending from a firstconnection to the second loop to a second connection to the second loop.189. The tissue manipulator of claim 145, wherein: the first loop isfree of cross-elements extending between any two parts of the firstloop.
 190. The tissue manipulator of claim 145, wherein: the second loopis free of cross-elements extending between any two parts of the secondloop.
 191. The tissue manipulator of claim 145, wherein: the third loopis free of cross-elements extending between any two parts of the thirdloop.
 192. The tissue manipulator of claim 145, further comprising: asource of suction coupled to the lumen.
 193. The tissue manipulator ofclaim 145, wherein: the first leg and the second leg of the first loopare both movable within the lumen.
 194. The tissue manipulator of claim145, wherein: the first leg and the second leg of the second loop areboth movable within the lumen.
 195. The tissue manipulator of claimPREV, wherein: the first leg and the second leg of the first loop arecoupled to an actuator extending through the lumen so that movement ofthe actuator moves the first leg and the second leg between thecollapsed position and the expanded position.
 196. The tissuemanipulator of claim PREV, wherein: the first leg and the second leg ofthe second loop are coupled to an actuator extending through the lumenso that movement of the actuator moves the first leg and the second legbetween the collapsed position and the expanded position.
 197. Thetissue manipulator of claim PREV, wherein: the first leg and the secondleg of the third loop are coupled to an actuator extending through thelumen so that movement of the actuator moves the first leg and thesecond leg between the collapsed position and the expanded position.198. The tissue manipulator of claim 145, wherein: the first loop ispositioned entirely distal to the distal opening in the expandedposition.
 199. The tissue manipulator of claim 145, wherein: the secondloop is positioned entirely distal to the distal opening in the expandedposition.
 200. The tissue manipulator of claim 145, wherein: the firstloop comprises a superelastic material within a superelastic range whenin the collapsed position; and the second leg comprises a superelasticmaterial within a superelastic range when in the collapsed position.201. The device of claim 145, further comprising: a rotating cutterhaving a cutting element at a distal end, the rotating cutter having aworking position adjacent the distal opening in the shaft.
 202. Thedevice of claim 145, wherein: the working position of the rotatingcutter has the cutting element positioned proximal to the distalopening.
 203. The device of claim 145, wherein: the rotating cutter iscoupled to the shaft and is longitudinally movable relative to the shaftto move the cutting element into the working position.
 204. The deviceof claim 145, wherein: the rotating cutter includes a lumen throughwhich material may be suctioned.
 205. A method of manipulating tissue inthe eye; comprising: introducing a distal end of a shaft within an eye,the shaft having a lumen with a distal opening also positioned in theeye; expanding a first loop from a collapsed position to an expandedposition within the eye, the first loop having a first leg and a secondleg, at least one of the first and second legs extending through thelumen, the first loop being movable from the collapsed position to theexpanded position when the at least one of the first and second legs isadvanced through the lumen and out the distal opening in the lumen;expanding a second loop from a collapsed position to an expandedposition within the eye, the second loop having a first leg and a secondleg, at least one of the first and second legs extending through thelumen, the second loop being movable from a collapsed position to anexpanded position when the at least one of the first and second legs isadvanced through the lumen and out the distal opening in the lumen. 206.The method of claim 205, further comprising: positioning material withinthe first loop; and collapsing the first loop from the expanded positiontoward the collapsed position so that the first loop is collapsed aroundthe material.
 207. The method of claim 205, further comprising: thepositioning is carried out with the material also positioned within thesecond loop; and collapsing the second loop from the expanded positiontoward the collapsed position so that the second loop is collapsedaround the material.
 208. The method of claim 205, wherein: the firstloop collapsing and the second loop collapsing are carried outsimultaneously.
 209. The method of claim 205, further comprising:cutting the material during the first loop collapsing.
 210. The methodof claim 205, further comprising: cutting the material during the secondloop collapsing.
 211. The method of claim 205, wherein: the expandingthe first loop and the expanding the second loop is carried outsimultaneously.
 212. The method of claim 205, wherein: the first loopexpanding is carried out with the first loop having an unbiased shape,wherein the unbiased shape of the first loop bounds an area defined inan orientation that maximizes the area, the area having an effectivediameter which is equal to the diameter of a circle having the area, thefirst loop moving toward the unbiased shape when moving from thecollapsed position to the expanded position.
 213. The method of claim205, wherein: the first loop expanding is carried out with the effectivediameter being 4.5 mm to 6.5 mm
 214. The method of claim 205, wherein:the first loop expanding is carried out with the effective diameterbeing 5.0 mm to 6.0 mm
 215. The method of claim 205, wherein: the secondloop expanding is carried out with the second loop having an unbiasedshape, wherein the unbiased shape of the second loop bounds an areadefined in an orientation that maximizes the area, the area having aneffective diameter which is equal to the diameter of a circle having thearea, the second loop moving toward the unbiased shape when moving fromthe collapsed position to the expanded position.
 216. The method ofclaim 205, wherein: the second loop expanding is carried out with theeffective diameter being 4.5 mm to 6.5 mm
 217. The method of claim 205,wherein: the second loop expanding is carried out with the effectivediameter being 5.0 mm to 6.0 mm
 218. The method of claim 205, wherein:the introducing is carried out with the shaft having a longitudinal axisat the distal end of the shaft; the first loop expanding is carried outwith the first loop having an orientation which maximizes an area of thefirst loop when in the expanded position when viewed along theorientation, the orientation being within 45 degrees of perpendicular tothe longitudinal axis.
 219. The method of claim 205, wherein: theintroducing is carried out with the shaft having a longitudinal axis atthe distal end of the shaft; the second loop expanding is carried outwith the second loop having an orientation which maximizes an area ofthe second loop when in the expanded position when viewed along theorientation, the orientation being within 45 degrees of perpendicular tothe longitudinal axis.
 220. The method of claim 205, wherein: the secondloop expanding is carried out so that the first loop and the second loopare spaced apart to define a volume therebetween when the first andsecond loops are in the expanded position, the volume therebetween being0.48 mm(3) to 0.84 mm(3).
 221. The method of claim 205, furthercomprising: deploying an intermediate element between the first loop andthe second loop.
 222. The method of claim 205, wherein: the deploying iscarried out with the intermediate element being a third loop positionedbetween the first loop and the second loop.
 223. The method of claim205, wherein: the deploying is carried out with the intermediate elementincluding an interconnecting element extending between the first loopand the second loop, the deploying being carried out during at least oneof the first loop expanding and the second loop expanding.
 224. Themethod of claim 205, wherein: the deploying is carried out with theinterconnecting element of the intermediate element being integrallyformed with the first loop and the second loop.
 225. The method of claim205, wherein: the deploying is carried out with the interconnectingelement being a flexible filament extending between the first loop andthe second loop.
 226. The method of claim 205, wherein: the deploying iscarried out with a third loop formed by the intermediate element havinga first leg and a second leg, at least one of the first and second legsextending through the lumen, the third loop being movable from acollapsed position to an expanded position when the at least one of thefirst and second legs of the third loop is advanced through the lumenand out the distal opening in the lumen.
 227. The method of claim 205,wherein: the deploying is carried out with the third loop having anunbiased shape, wherein the unbiased shape of the third loop bounds anarea defined in an orientation that maximizes the area, the area havingan effective diameter which is equal to the diameter of a circle havingthe area, the third loop moving toward the unbiased shape when movingfrom the collapsed position to the expanded position.
 228. The method ofclaim 205, wherein: the deploying is carried out with the effectivediameter of the area of the third loop being 4.5 mm to 6.5 mm.
 229. Themethod of claim 205, wherein: the deploying is carried out with theeffective diameter of the area of the third loop being 5.0 mm to 6.0 mm.230. The method of claim 205, wherein: the introducing is carried outwith the shaft having a longitudinal axis at the distal end of theshaft; the deploying is carried out with the third loop having anorientation which maximizes an area of the first loop when in theexpanded position when viewed along the orientation, the orientationbeing within 30 degrees of perpendicular to the longitudinal axis. 231.The method of claim 205, further comprising: collapsing the third loopfrom the expanded position toward the collapsed position, the third loopbeing configured to cut material contained within the third loop whenthe third loop moves from the expanded position toward the collapsedposition.
 232. The method of claim 205, wherein: the second loopexpanding defines an exposed surface between the first loop and thesecond loop when the first and second loops are both in the expandedposition.
 233. The method of claim 205, wherein: the second loopexpanding is carried out with the exposed surface between the first loopand the second loop having an area of 15 mm(3) to 60 mm(3).
 234. Themethod of claim 205, wherein: the first loop expanding is carried outwith the first loop having an unbiased shape, wherein the unbiased shapeof the first loop bounds an area defined by an orientation thatmaximizes the area, the area having an effective diameter which is equalto the diameter of a circle having the area, the first loop movingtoward the unbiased shape when moving from the collapsed position to theexpanded position; the second loop expanding is carried out to define anexposed surface between the first loop and the second loop, the exposedsurface being 3-10 times the effective diameter of the area of the firstloop in the unbiased shape.
 235. The method of claim 205, wherein: thesecond loop expanding is carried out with the exposed surface betweenthe first loop and the second loop having 2-8 independent cells. 236.The method of claim 205, wherein: the second loop expanding is carriedout with the exposed surface between the first loop and the second loophaving 2-6 independent cells.
 237. The method of claim 205, wherein: thesecond loop expanding is carried out with the exposed surface betweenthe first loop and the second loop having 2-4 independent cells. 238.The method of claim 205, wherein: the second loop expanding is carriedout with the exposed surface between the first loop and the second loophaving 2 independent cells.
 239. The method of claim 205, wherein: thesecond loop expanding is carried out with the exposed surface being atleast 4 times larger than an area of the intermediate element positionedbetween the first loop and the second loop.
 240. The method of claim205, wherein: the second loop expanding is carried out with the firstloop having at least 80% of the loop being 1.5-3.5 mm from the secondloop.
 241. The method of claim 205, further comprising: extending afirst support element from a distal end of the shaft, the first supportelement being an elongate element that extends to a free end.
 242. Themethod of claim 205, wherein: the extending is carried out with thefirst support element being positioned with the free end positionedwithin an area of the first loop when viewing the first loop along anorientation that maximizes the area of the first loop.
 243. The methodof claim 205, wherein: the extending is carried out with the first loophaving an effective diameter when in the expanded position, theeffective diameter being a diameter of a circle having the area of thefirst loop in the expanded position; and the first support extending iscarried out so that the first support element extends into the area ofthe first loop so that the free end is positioned 0.05 to 0.30 times theeffective diameter of the first loop when viewed along the orientation.244. The method of claim 205, wherein: the first support extending iscarried out simultaneously with the first loop expanding.
 245. Themethod of claim 205, further comprising: extending a second supportelement from the distal end of the shaft, the second support elementbeing an elongate element that extends to a free end.
 246. The method ofclaim 205, wherein: the second support element extending is carried outwith the free end positioned within an area of the second loop whenviewing the second loop along an orientation that maximizes the area ofthe second loop.
 247. The method of claim 245, wherein: the secondsupport element extending is carried out with the second loop having aneffective diameter when in the expanded position, the effective diameterbeing a diameter of a circle having the area of the second loop in theexpanded position, the second support element extends into the area ofthe second loop so that the free end is positioned 0.05 to 0.30 timesthe effective diameter of the second loop.
 248. The method of claim 245,wherein: the second support element extending is carried outsimultaneously with the second loop expanding.
 249. The method of claim205, further comprising: the second loop expanding is carried out withthe first loop having at least one interconnecting element extendingfrom a first connection to the first loop to a second connection to thefirst loop, the interconnecting element being deployed during at leastthe second loop expanding, the second loop also having at least oneinterconnecting element extending from a first connection to the secondloop to a second connection to the second loop.
 250. The method of claim205, wherein: the first loop expanding is carried out with the firstloop being free of cross-elements extending between any two parts of thefirst loop.
 251. The method of claim 205, wherein: the second loopexpanding is carried out with the second loop being free ofcross-elements extending between any two parts of the second loop. 252.The method of claim 205, wherein: the deploying is carried out with thethird loop being free of cross-elements extending between any two partsof the third loop.
 253. The method of claim 205, further comprising:suctioning the material into the lumen through the distal opening. 254.The method of claim 205, wherein: the first loop expanding is carriedout independently of the second loop expanding.
 255. The method of claim205, wherein: the first loop expanding is carried out with the first legand the second leg of the first loop being coupled to an actuatorextending through the lumen so that movement of the actuator moves thefirst leg and the second leg between the collapsed position and theexpanded position.
 256. The method of claim 205, wherein: the secondloop expanding is carried out with the first leg and the second leg ofthe second loop being coupled to an actuator extending through the lumenso that movement of the actuator moves the first leg and the second legbetween the collapsed position and the expanded position.
 257. Themethod of claim 205, wherein: the deploying is carried out with thefirst leg and the second leg of the third loop being coupled to anactuator extending through the lumen so that movement of the actuatormoves the first leg and the second leg between the collapsed positionand the expanded position.
 258. The method of claim 205, wherein: thefirst loop expanding is carried out with the first loop being positionedentirely distal to the distal opening in the expanded position.
 259. Themethod of claim 205, wherein: the second loop expanding is carried outwith the second loop being positioned entirely distal to the distalopening in the expanded position.
 260. The method of claim 205, wherein:the first loop expanding is carried out with the first loop including asuperelastic material within a superelastic range when in the collapsedposition; and the second loop expanding is carried out with the secondloop including a superelastic material within a superelastic range whenin the collapsed position.
 261. The method of claim 205, furthercomprising: cutting material with a rotating cutter having a cuttingelement at a distal end, the rotating cutter having a working positionadjacent the distal opening in the shaft.
 262. The method of claim 205,wherein: the rotating cutter cutting is carried out with the workingposition having the cutting element positioned proximal to the distalopening.
 263. The method of claim 205, wherein: the rotating cuttercutting is carried out with is coupled to the shaft and islongitudinally movable relative to the shaft to move the cutting elementinto the working position.
 264. The method of claim 205, wherein: therotating cutter cutting is carried out with the rotating cutterincluding a lumen.
 265. The method of claim 205, further comprising:suctioning material through the lumen in the rotating cutter.
 266. Themethod of claim 265, wherein: the suctioning with the rotating cutter iscarried out during the cutting with the rotating cutter.
 267. A tissuemanipulator, comprising: a first loop having a first leg and a secondleg, at least one of the first and second legs extending through thelumen, the first loop being movable from a collapsed position to anexpanded position when the at least one of the first and second legs isadvanced through a lumen in a shaft and out a distal opening in thelumen; and a concave element coupled to the first loop, the concaveelement and the loop forming a basket to receive material.
 268. Thetissue manipulator of claim 267, wherein: the shaft is configured forintroduction into the eye so that a distal end and the distal openingare positioned in the eye.
 269. The tissue manipulator of claim 267,wherein: the concave element is integrally formed with the loop. 270.The tissue manipulator of claim 267, wherein: the concave element has afirst end and a second end, the first end being integrally formed withthe loop.
 271. The tissue manipulator of claim 267, wherein: the secondend of the concave element is integrally formed with the loop.
 272. Thetissue manipulator of claim 267, wherein: the second end of the concaveelement is movable within the lumen of the shaft.
 273. The tissuemanipulator of claim 267, wherein: the first leg and the second leg areboth movable within the lumen of the shaft.
 274. The tissue manipulatorof claim 267, wherein: the second leg of the concave element isindependently movable within the lumen of the shaft from the at leastone of the first and second legs.
 275. The tissue manipulator of claim267, wherein: the loop is made of a superelastic material.
 276. Thetissue manipulator of claim 267, wherein: the concave element is made ofa superelastic material.
 277. The tissue manipulator of claim 267,wherein: the shaft has a longitudinal axis at a distal end; and the loophas an orientation which maximizes an area of the loop when in theexpanded position, the orientation being within 30 degrees fromperpendicular to the longitudinal axis.
 278. The tissue manipulator ofclaim 267, wherein: the loop is positioned entirely distal to the distalopening when in the expanded position.
 279. The device of claim 267,further comprising: a rotating cutter having a cutting element at adistal end, the rotating cutter having a working position adjacent thedistal opening in the shaft.
 280. The device of claim 267, wherein: theworking position of the rotating cutter has the cutting elementpositioned proximal to the distal opening.
 281. The device of claim 267,wherein: the rotating cutter is coupled to the shaft and islongitudinally movable relative to the shaft to move the cutting elementinto the working position.
 282. The device of claim 267, wherein: therotating cutter includes a lumen through which material may besuctioned.
 283. A method of manipulating tissue within an eye,comprising: introducing a distal end of a shaft into an eye, the shafthaving a lumen with a distal opening, a first loop having a first legand a second leg being coupled to the shaft, at least one of the firstand second legs extending through the lumen, the first loop beingmovable from a collapsed position to an expanded position when the atleast one of the first and second legs is advanced through the lumen andout the distal opening in the lumen, a concave element being coupled tothe first loop, the concave element and the loop forming a basket toreceive material; expanding the loop from the collapsed position to theexpanded position; manipulating the basket to position material in thebasket; and collapsing the loop so that the material is held within thebasket.
 284. The method of claim 283, wherein: the collapsing is carriedout with the concave element being integrally formed with the loop. 285.The method of claim 283, wherein: the collapsing is carried out with theconcave element having a first end and a second end, the first end beingintegrally formed with the loop.
 286. The method of claim 283, wherein:the collapsing is carried out with the second end of the concave elementbeing integrally formed with the loop.
 287. The method of claim 283,wherein: the collapsing is carried out with the second end of theconcave element being movable within the lumen of the shaft.
 288. Themethod of claim 283, wherein: the introducing is carried out with thefirst leg and the second leg both movable within the lumen of the shaft.289. The method of claim 283, wherein: the introducing is carried outwith the second leg of the concave element being independently movablewithin the lumen of the shaft from the at least one of the first andsecond legs.
 290. The method of claim 283, wherein: the introducing iscarried out with the loop comprising made of a superelastic material.291. The method of claim 283, wherein: the introducing is carried outwith the concave element comprising made of a superelastic material.292. The method of claim 283, wherein: the introducing is carried outwith the shaft having a longitudinal axis at a distal end; and theexpanding is carried out with the loop having an orientation whichmaximizes an area of the loop when in the expanded position, theorientation being within 30 degrees from perpendicular to thelongitudinal axis.
 293. The method of claim 283, wherein: the expandingis carried out with the loop being positioned entirely distal to thedistal opening when in the expanded position.
 294. The method of claim283, wherein: the collapsing cuts the material contained within thebasket.
 295. The method of claim 283, further comprising: suctioningmaterial into the lumen of the shaft.
 296. The method of claim 283,further comprising: cutting material with a rotating cutter having acutting element at a distal end, the rotating cutter having a workingposition adjacent the distal opening in the shaft.
 297. The method ofclaim 283, wherein: the rotating cutter cutting is carried out with theworking position having the cutting element positioned proximal to thedistal opening.
 298. The method of claim 283, wherein: the rotatingcutter cutting is carried out with is coupled to the shaft and islongitudinally movable relative to the shaft to move the cutting elementinto the working position.
 299. The method of claim 283, wherein: therotating cutter cutting is carried out with the rotating cutterincluding a lumen.
 300. The method of claim 283, further comprising:suctioning material through the lumen in the rotating cutter.
 301. Themethod of claim 300, wherein: the suctioning with the rotating cutter iscarried out during the cutting with the rotating cutter.
 302. A tissuemanipulator, comprising a first shaft having a first lumen with a distalopening; a second shaft extending through the first lumen of the firstshaft; a first loop having a first leg and a second leg, at least one ofthe first and second legs extending through the first lumen, the firstloop being movable from a collapsed position to an expanded positionwhen the at least one of the first and second legs is advanced throughthe first lumen and out the distal opening in the first lumen; and asecond loop having a first leg and a second leg, at least one of thefirst and second legs extending through the first lumen, the second loopbeing movable from a collapsed position to an expanded position when theat least one of the first and second legs is advanced through the lumenand out the distal opening in the lumen.
 303. The tissue manipulator ofclaim 302, further comprising: a first concave element coupled to thefirst loop, the first concave element and the first loop forming a firstbasket; a second concave element coupled to the second loop, the secondconcave element and the second loop forming a second basket.
 304. Thetissue manipulator of claim 302, wherein: the first concave elementincludes a first concave shaped loop; and the second concave elementincludes a second concave shaped loop.
 305. The tissue manipulator ofclaim 302, wherein: the second shaft is rotatable relative to the firstshaft so that the second basket is rotatable relative to the firstbasket between an open position and a closed position, the open positionhaving the first basket and the second basket at least partially nestedand the closed position having the first basket facing the secondbasket.
 306. The tissue manipulator of claim 302, wherein: the secondshaft is rotatable to the closed position with the first basket and thesecond basket forming an enclosure.
 307. The tissue manipulator of claim302, wherein: the first loop is configured to cut material when thefirst loop is moved from the expanded position to the collapsedposition.
 308. The device of claim 302, further comprising: a rotatingcutter having a cutting element at a distal end, the rotating cutterhaving a working position adjacent the distal opening in the shaft. 309.The device of claim 302, wherein: the working position of the rotatingcutter has the cutting element positioned proximal to the distalopening.
 310. The device of claim 302, wherein: the rotating cutter iscoupled to the shaft and is longitudinally movable relative to the shaftto move the cutting element into the working position.
 311. The deviceof claim 302, wherein: the rotating cutter includes a lumen throughwhich material may be suctioned.
 312. A method of manipulating tissue,comprising: introducing a device having a first shaft and a second shaftinto an eye, the first shaft having a first lumen with a distal opening,the second shaft extending through the lumen of the first shaft, a firstloop having a first leg and a second leg coupled to at least one of thefirst shaft and the second shaft, at least one of the first and secondlegs extending through the first lumen, the first loop being movablefrom a collapsed position to an expanded position when the at least oneof the first and second legs is advanced through the first lumen and outthe distal opening in the first lumen, a second loop having a first legand a second leg, at least one of the first and second legs extendingthrough the lumen, the second loop being movable from a collapsedposition to an expanded position when the at least one of the first andsecond legs is advanced through the second lumen and out the distalopening in the lumen, a first concave element coupled to the first loop,the first concave element and the first loop forming a first basket, asecond concave element coupled to the second loop, the second concaveelement and the second loop forming a second basket; expanding the firstloop; expanding the second loop; and rotating the first loop and secondloop relative to one another about a longitudinal axis of the firstshaft.
 313. The method of claim 323, wherein: the introducing is carriedout with the first concave element including a first concave shaped loopand the second concave element includes a second concave shaped loop.314. The method of claim 323, wherein: the rotating is carried out withthe second shaft being rotatable relative to the first shaft so that thesecond basket is rotatable relative to the first basket between an openposition and a closed position, the open position having the firstbasket and the second basket at least partially nested and the closedposition having the first basket facing the second basket.
 315. Themethod of claim 323, wherein: the rotating is carried out with thesecond shaft rotatable to the closed position with the first basket andthe second basket forming an enclosure.
 316. The method of claim 323,further comprising: cutting the material by collapsing the first loopand the second loop to cut material when the first loop and the secondloop are moved from the expanded position to the collapsed position.317. The method of claim C, further comprising: cutting material with arotating cutter having a cutting element at a distal end, the rotatingcutter having a working position adjacent the distal opening in theshaft.
 318. The method of claim 323, wherein: the rotating cuttercutting is carried out with the working position having the cuttingelement positioned proximal to the distal opening.
 319. The method ofclaim 323, wherein: the rotating cutter cutting is carried out with iscoupled to the shaft and is longitudinally movable relative to the shaftto move the cutting element into the working position.
 320. The methodof claim 323, wherein: the rotating cutter cutting is carried out withthe rotating cutter including a lumen.
 321. The method of claim 323,further comprising: suctioning material through the lumen in therotating cutter.
 322. The method of claim 321, wherein: the suctioningwith the rotating cutter is carried out during the cutting with therotating cutter.
 323. A method of cutting a lens in a cataractprocedure, comprising: introducing a distal end of a device into an eye,the device having a shaft and an elongate element coupled to the shaft,the shaft having a first shaft part and a second shaft part, the firstshaft part and the second shaft part being movable relative to oneanother between a first position and a second position, the elongateelement having a first end coupled to the first shaft part and a secondend coupled to the second shaft part, the device forming a loop with atleast part of the elongate element forming the loop, the loop beingmovable from a collapsed position to an expanded position when the firstshaft part and the second shaft part move from the first position to thesecond position; expanding the loop from the collapsed position to theexpanded position by moving the first and second shaft parts from thefirst position to the second position; positioning the loop aroundmaterial to be cut; and cutting the material by collapsing the loop fromthe expanded position toward the collapsed position, the loop beingcollapsed by moving the first and second shaft parts from the secondposition toward the first position to cut the material positioned withinthe loop.
 324. The method of claim 323, wherein: the expanding iscarried out with the loop advancing between a capsular bag and a wholelens contained within the capsular bag; the positioning is carried outwith the material being a whole lens, the loop being positioned aroundan anterior surface and a posterior surface of the lens; and the cuttingis carried with the whole lens being separated into at least a firstfragment and a second fragment.
 325. The method of claim 323, wherein:the first flexible portion has a length of 20-60% of a length of theintermediate portion.
 326. The method of claim 323, wherein: theintroducing is carried out with the elongate element having a firstflexible portion at the first end, wherein an intermediate portionbetween the first end and the second end is at least 1.5 more stiff thanthe first flexible portion.
 327. The method of claim 323, wherein: theintroducing is carried out with the elongate element having a secondflexible portion at the second end, wherein the intermediate portionbetween the first end and the second end is at least 1.5 more stiff thanthe second flexible portion.
 328. The method of claim 323, wherein: theexpanding is carried out with the first end having an orientation thatchanges an angular orientation by at least 120 degrees with respect tothe shaft adjacent to the second end of the elongate element when thefirst and second shaft parts move from the first position to the secondposition.
 329. The method of claim 323, wherein: the expanding iscarried out with the first end being coupled to a flexible distal end ofthe shaft, the flexible distal end of the shaft changing orientationwith respect to the shaft adjacent the second end by at least 30 degreeswhen the first and second shaft parts move from the first position tothe second position.
 330. The method of claim 323, wherein: theexpanding is carried out with the first end being rotatably coupled tothe shaft.
 331. The method of claim 323, wherein: the expanding iscarried out with the first end being rotatable relative to the shaft foran angle of at least 120 degrees.
 332. The method of claim 323, wherein:the expanding is carried out with the first end being rotatably coupledto the shaft to rotate for 180 degrees+/−45 degrees when the first andsecond shaft parts move from the first position to the second position.333. The method of claim 323, wherein: the expanding is carried out withthe loop advancing distally beyond a distal end of the shaft as the loopmoves from the collapsed position to the expanded position.
 334. Themethod of claim 323, wherein: the expanding is carried out with thesecond end changing in orientation relative to the shaft adjacent thesecond end by 90 degrees+/−45 degrees when the first and second shaftparts move from the first position to the second position.
 335. Themethod of claim 323, wherein: the expanding is carried out with thesecond end being rotating relative to the shaft when the first andsecond shaft parts move from the first position to the second position.336. The method of claim 323, wherein: the expanding is carried out withthe second end changing an orientation with respect to the shaftadjacent the second end being rotatably coupled to the shaft to rotatefor 90 degrees+/−45 degrees when the first and second shaft parts movefrom the first position to the second position.
 337. The method of claim323, wherein: the introducing is carried out with the elongate elementbeing without a preset shape.
 338. The method of claim 323, wherein: theintroducing is carried out with the elongate element not including asuperelastic material.
 339. The method of claim 323, wherein: theexpanding is carried out with the loop moving from an unbiased positiontoward a biased position when moving from the collapsed position to theexpanded position.
 340. A device for cutting material, comprising: ashaft having a distal end, the shaft having a first shaft part and asecond shaft part, the first shaft part and the second shaft part beingmovable relative to one another between a first position and a secondposition; and an elongate element coupled to the shaft, the elongateelement having a first end coupled to the first shaft part and a secondend coupled to the second shaft part, at least part of the elongateelement forming a loop, the loop being movable from a collapsed positionto an expanded position when the first shaft part and the second shaftpart move from the first position to the second position.
 341. Thedevice of claim 340, wherein: the loop is advanced between a capsularbag and a whole lens contained within the capsular bag in use whenexpanded from the collapsed position to the expanded position. the loopbeing movable around an anterior surface and a posterior surface of thewhole lens to separate the whole lens into at least a first fragment anda second fragment.
 342. The device of claim 340, wherein: the elongateelement has a first flexible portion at the first end and a secondflexible portion at the second end, wherein an intermediate portionbetween the first end and the second end is at least 1.5 more stiff inbending than the first and second flexible portions when expanding. 343.The device of claim 340, wherein: the first flexible portion has alength of 20-60% of a length of the intermediate portion.
 344. Thedevice of claim 340, wherein: the first end has an orientation thatchanges by at least 120 degrees with respect to the shaft at the secondend of the elongate element when the first and second shaft parts movefrom the first position to the second position.
 345. The device of claim340, wherein: the shaft has a flexible distal end coupled to the firstend, the flexible distal end of the shaft changing orientation withrespect to the shaft adjacent the second end by at least 30 degrees whenthe first and second shaft parts move from the first position to thesecond position; and the first end of the elongate element being coupledto a flexible distal end of the shaft,
 346. The device of claim 340,wherein: the first end is rotatably coupled to the shaft.
 347. Thedevice of claim 340, wherein: the first end is rotatable relative to theshaft for an angle of at least 120 degrees.
 348. The device of claim340, wherein: the first end being rotatably coupled to the shaft torotate for 180 degrees+/−45 degrees when the first and second shaftparts move from the first position to the second position.
 349. Thedevice of claim 340, wherein: the loop formed at least in part by theelongate element advances distally beyond a distal end of the shaft asthe loop moves from the collapsed position to the expanded position.350. The device of claim 340, wherein: the second end changes inorientation relative to the shaft adjacent the second end by 90degrees+/−45 degrees when the first and second shaft parts move from thefirst position to the second position.
 351. The device of claim 340,wherein: the second end rotates relative to the shaft when the first andsecond shaft parts move from the first position to the second position.352. The device of claim 340, wherein: the second end changes anorientation with respect to the shaft adjacent the second end and isrotatably coupled to the shaft to rotate for 90 degrees+/−45 degreeswhen the first and second shaft parts move from the first position tothe second position.
 353. The device of claim 340, wherein: the firstend of the elongate element is rotatably coupled to the shaft.
 354. Thedevice of claim 340, wherein: the first end of the elongate element isrotatable relative to the shaft for an angle of at least 120 degrees.355. The device of claim 340, wherein: the first end of the elongateelement is rotatably coupled to the shaft to rotate for 180 degrees+/−45degrees when the first and second shaft parts move from the firstposition to the second position.
 356. The device of claim 340, wherein:the first end of the elongate element rotates so that the loop advancesdistally beyond a distal end of the shaft as the loop moves from thecollapsed position to the expanded position.
 357. The device of claim340, wherein: the second end of the elongate element is rotatablycoupled to the shaft.
 358. The device of claim 340, wherein: the secondend of the elongate element is rotatable relative to the shaft for anangle of at least 120 degrees when the first and second shaft parts movefrom the first position to the second position.
 359. The device of claim340, wherein: the second end of the elongate element is rotatablycoupled to the shaft to rotate for 180 degrees+/−45 degrees when thefirst and second shaft parts move from the first position to the secondposition.
 360. The device of claim 340, wherein: the second end of theelongate element rotates relative to the shaft so that the loop advancesproximally as the loop moves from the collapsed position to the expandedposition.
 361. The device of claim 340, wherein: the elongate element iswithout a preset shape.
 362. The device of claim 340, wherein: theelongate element does not include a superelastic material.
 363. Thedevice of claim 340, wherein: the loop formed at least in part by theelongate element moves from an unbiased position toward a biasedposition when moving from the collapsed position to the expandedposition.
 364. An ocular surgical device comprised of: hand held piece asuction mechanism manually activated by a user a source of pressurizedfluid wherein the hand held piece is connected to the suction mechanismand the source of fluid a user input on the hand held mechanism forcontrolling the flow of suction or fluid a tip on the distal end of thehand held piece capable of providing both suction and delivery of fluid